gov lk

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

MSL/307/21 (SILMD/2021/02419)

Osimertinib Film Coated Tablets 80mg

Tagrisso

Astrazeneca AB, Sweden

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/152/22

Rosuvastatin Tablets IP 20mg

ROSVOR-20

Pharmafabrikon,India

Novachem Lanka (Pvt) Ltd

Accepted for Review

MSL/153/22

Pantoprazole Tablets 40mg

PANOVA - 40

Pharmafabrikon,India

Novachem Lanka (Pvt) Ltd

Accepted for Review

MSL/591/22

Somatropin Solution for Injection 60IU/3ml (Recombinant human growth hormone (r-hu-GH)

HHT PEN

Biosidus S.A , Argentina

ABC Pharma Services (Pvt) Ltd

Accepted for Review

MSL/761/22

Tobramycin Eye Ointment 0.3% w/w

Nebra

Remington Pharmaceuticals Industries, Pakistan

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/770/22

Ranolazine Extended Release Tablets 750mg

RANOZ 750

Cadila Healthcare Ltd,India

Zydus Lanka (Pvt) Ltd

Rejected

MSL/1010/22

Ursodeoxycholic Acid Tablets BP 300mg

ULIV 300

The Acme Laboratories Ltd,Banglsdesh

Mega Pharma (Pvt) Ltd

Accepted for Review

MSL/1011/22

Ursodeoxycholic Acid Tablets BP 150mg

ULIV 150

The Acme Laboratories Ltd,Banglsdesh

Mega Pharma (Pvt) Ltd

Accepted for Review

MSL/1013/22

Tranexamic Acid Injection BP 100mg/ml

ZENMIC

Zen Pharma Pvt Ltd, India

Radiant Healthcare (Pvt) Ltd

Accepted for Review

MSL/1029/22

Hypromellose Eye Drops USP 0.7% w/v

MOISOL EYE DROPS

FDC Limited, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1049/22

Ribociclib Film Coated Tablet 200mg

Kryxana

Lek Pharmaceuticals d.d, Slovenia

A.Baur & Co (Pvt) Ltd

Accepted for Review

MSL/1100/22

Mometasone Furoate Cream USP 0.1% w/w

MOMTAS

Blossom Pharmaceuticals, India for Oaknet Healthcare Pvt Ltd,India

George Steuart Health (Pvt) Ltd

Accepted for Review

MSL/1101/22

Simethicone 40mg Chewable Tablet

AIR-X SF (CHEWABLE TABLET)

R.X Manufacturing Company Limited, Thailand

Emerchemie NB Ceylon Limited

Rejected

MSL/1102/22

Simethicone 80mg Chewable Tablet

AIR-X ORANGE FLAVOURED (CHEWABLE TABLET)

R.X Manufacturing Company Limited, Thailand

Emerchemie NB Ceylon Limited

Rejected

MSL/1103/22

Simethicone 120mg Chewable Tablet

AIR-X 120 (CHEWABLE TABLETS)

R.X Manufacturing Company Limited, Thailand

Emerchemie NB Ceylon Limited

Rejected

MSL/1116/22

Sacubitril and Valsartan Tablets 49/51mg

Covalsec -OS

The Madras Pharmaceuticals,India

Pharma Associates

Accepted for Review

MSL/1117/22

Sacubitril and Valsartan Tablets 24/26mg

Covalsec

The Madras Pharmaceuticals,India

Pharma Associates

Accepted for Review

MSL/1138/22

Budesonide & Formoterol Powder for Inhalation IP 200 mg/ 6cmg

FORMONIDE 200 RESPICAP

Zydus Healthcare Limited,India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1139/22

Budesonide & Formoterol Powder for Inhalation IP 400 mg/ 6cmg

FORMONIDE 400 RESPICAP

Zydus Healthcare Limited,India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1219/22

Micronized Progesterone Capsules USP 100 mg

UTROGEST-100

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1237/22

Etanercept (r-DNA Origin) Injection 50mg/ml

Nepexto

Lupin Limited (Biotech Division) , India

Ceyoka (Pvt) Ltd

Accepted for Review

MSL/1245/22

Apixaban Tablet 5mg

ZILERO 5

PharmEvo (Pvt) Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/1250/22

Azithromycin Tablets USP 500mg

Zithrin

Renata Ltd, Bangladesh

Emerchemie NB Ceylon Limited

Accepted for Review

MSL/1265/22

Terbinafine Topical Solution 1% w/w (Inhaler)

Terbiderm

Atco Laboratories Limited, Pakistan

Morison Limited

Accepted for Review

MSL/06/2023

Linagliptin Tablets 5mg

Linapride-5

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/07/2023

Empagliflozin Tablets 10mg

Empapride 10

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/08/2023

Empagliflozin Tablets 25mg

Empapride 25

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/09/2023

Mebendazole Tablets USP 100mg

MEBZOLE 100

Concept Pharmaceuticals Ltd,India

Softcare International (Pvt) Ltd

Accepted for Review

MSL/11/2023

Povidone Iodine Topical Solution USP 10% w/v

SOLUDINE 10%

Lincoln Pharmaceuticals Ltd, India

Pharmatec (Pvt) Ltd

Accepted for Review

MSL/12/2023

Cetirizine Hydrochloride Tablets 10mg

SATRIN

Lincoln Pharmaceuticals Ltd, India

Pharmatec (Pvt) Ltd

Accepted for Review

MSL/14/2023

Atorvastatin Calcium Tablets USP 20mg

VAST-20

Lincoln Pharmaceuticals Ltd, India

Pharmatec (Pvt) Ltd

Rejected

MSL/15/2023

Amisulpride Tablet 200mg

AMPICON-200

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/16/2023

Levetiracetam Tablets 250mg

LEVECON- 250

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/17/2023

Levetiracetam Tablets 500mg

LEVECON-500

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/18/2023

Clozapine Tablet 100mg

PSYCLOZE-100

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/19/2023

Thiamine Hydrochloride 100mg Tablet

THISORT-100

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/20/2023

Meloxicam Tablets 7.5mg

Veraxa 7.5

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/21/2023

Fluconazole Capsules 50mg

Flunaz 50

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/22/2023

Phenytoin Sodium 100mg Tablet

SEZTIN-100

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/23/2023

Levetiracetam Tablets 250mg

Vectam 250

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/24/2023

Levetiracetam Tablets 500mg

Vectam 500

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/25/2023

Ivabradine Tablets 5mg

Noracor

Atco Laboratories Limited,Pakistan

Morison Limited

Accepted for Review

MSL/26/2023

Ivabradine Tablets 7.5mg

Noracor

Atco Laboratories Limited,Pakistan

Morison Limited

Accepted for Review

MSL/27/2023

Terbinafine HCL Tablet USP 500mg

TERBIZINE TABLET

Candid Pharmaceuticals,Pakistan

Bio Tech Pharma (Pvt) Ltd

Rejected

MSL/28/2023

Terbinafine HCL Tablets USP 250mg

TERBIZINE TABLET

Candid Pharmaceuticals,Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/33/2023

Vildagliptin Tablet 50mg

RANIPTIN TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/34/2023

Azithromycin Tablets USP 250mg

AZITHROTAB 250

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Rejected

MSL/35/2023

Azithromycin Tablets USP 500mg

AZITHROTAB 500

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Rejected

MSL/36/2023

Ondansetron Tablets 8mg

Vemtix

Bio-Labs (Pvt) Limited, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/38/2023

Levetiracetam Tablet 750mg

Vectam 750

Bio-Labs (Pvt) Limited, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/39/2023

Levetiracetam Tablet 1000mg

Vectam 1000

Bio-Labs (Pvt) Limited, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/40/2023

Azathioprine Tablets 50mg

Demard 50

Bio-Labs (Pvt) Limited, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/41/2023

Telmisartan Tablets USP 80mg

Telmiclar 80

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/42/2023

Telmisartan Tablets USP 40mg

Telmiclar 40

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/43/2023

Gatifloxacin Eye Drops 0.3% w/v

Gate

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/44/2023

Ofloxacin Tablets USP 200mg

Orixo 200

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/45/2023

Ofloxacin Tablets USP 400mg

Orixo 400

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/46/2023

Mometasone Furoate Cream 0.1% w/w

Momaderm

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/47/2023

Hydroquinone 2% w/w and Tretinoin Cream 0.025% w/w cream

Melalong

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/48/2023

Tacrolimus Ointment 0.03% w/w

Talimus 0.03

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/49/2023

Adapalene 0.1% w/w + Clindamycin Phosphate 1% w/w Gel

Adacin

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for review

MSL/50/2023

Irbesartan and Hydrochlorothiazide Tablets USP 150/12.5mg

IRSAR-H

Bafna Pharmaceuticals Ltd,India

Pharma Associates

Accepted for Review

MSL/51/2023

Tacrolimus Ointment 0.1% w/w

Talimus 0.1

Ajanta Pharma Limited,India

A.Baur & Co. (Pvt) Ltd

Accepted for Review

MSL/52/2023

Povidone Iodine Ointment USP 5% w/w

NOSEPT

Laborate Pharmaceuticals India Ltd, India

ABC Pharma Services (Pvt) Ltd

Accepted for Review

MSL/53/2023

Domperidone Tablet 10mg

Vave 10 Tablet

Advanced Chemical Industries Limited,Bngladesh

CIC Holdings PLC

Rejected

MSL/54/2023

Domperidone Suspension 5mg/5ml

Vave Suspension

Advanced Chemical Industries Limited,Bngladesh

CIC Holdings PLC

Accepted for Review

MSL/55/2023

Pregabalin Capsule BP 50mg

Lyrigab-50

Baader Schulz Laboratories Pvt Ltd, India

Radiant Healthcare Pvt Ltd

Accepted for Review

MSL/56/2023

Aceclofenac Tablets BP 100mg

CECLOF

Baader Schulz Laboratories Pvt Ltd, India

Radiant Healthcare Pvt Ltd

Accepted for review

MSL/57/2023

Vitamin E Capsule 400mg USP

EVIROSE-400

XL Laboratories (Pvt) Ltd, India

SMM Halcyon (Pvt) Ltd

Accepted for Review

MSL/58/2023

Lidocaine Gel BP 2% w/w

Zencaine Gel

Nanz Med Science Pharma Pvt Ltd,India

SMM Halcyon (Pvt) Ltd

Accepted for Review

MSL/59/2023

Povidone lodine cleansing solution USP 7.5% w/w

Germidine Surgical Scrub

Nanz Med Science Pharma Pvt Ltd,India

SMM Halcyon (Pvt) Ltd

Accepted for Review

MSL/62/2023

Human Albumin Solution 20% w/v

SK Albumin 20% Injection

SK Plasma Co Ltd,Republic of Korea

Ceyoka (Pvt) Ltd

Accepted for Review

MSL/63/2023

Human Normal Immunoglobulin for intravenous Administration 5% w/v

Liv-Gamma SN Injection

SK Plasma Co Ltd,Republic of Korea

Ceyoka (Pvt) Ltd

Accepted for Review

MSL/64/2023

Levetiracetam Tablet USP 500mg

Lepitam 500mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/65/2023

Levetiracetam Tablet USP 250mg

Lepitam 250mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/66/2023

Desloratadine Tablet BP 5mg

Desotin 5mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/67/2023

Risperidone Tablet USP 2mg

Redone 2mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/68/2023

Risperidone Tablet USP 4mg

Redone 2mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/69/2023

Sertraline Hydrochloride Tablet USP 100mg

Aine 100mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/70/2023

Sertraline Hydrochloride Tablet USP 50mg

Aine 50mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/71/2023

Calcium Carbonate 500mg + Cholecalciferol 250IU Tablet BP

(Calrise D3)

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Rejected

MSL/72/2023

Olanzapine Tablet USP 10mg

Olzarise 10

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/73/2023

Ofloxacin Tablet USP 200mg

Ofsun 200

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/74/2023

Sildenafil Citrate Tablet USP 50mg

Risegra 50

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/75/2023

Tramadol Capsule BP 50mg

Riseol 50

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/76/2023

Sertraline Tablet USP 50mg

Sertrasun 50

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/77/2023

Risperidone Tablet USP 2mg

Ryspesun 2

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/78/2023

Amlodipine Tablet USP 5mg

Cardisure 5

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Rejected

MSL/79/2023

Acetazolamide Tablet BP 250mg

Acetarise 250

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for review

MSL/80/2023

Tranexamic Acid Tablet BP 500mg

Tranesun 500

Sunrise International Labs Limited,India

Zyrex Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/85/2023

Pemetrexed for Injection 100mg/Vial

PEMTERO 100

Hetero Labs Limited,India

Mansel (Ceylon) (Pvt) Ltd

Accepted for Review

MSL/86/2023

Bendamustine Hydrochloride for Injection 100mg

BENTERO 100

Hetero Labs Limited,India

Mansel (Ceylon) (Pvt) Ltd

Accepted for Review

MSL/88/2023

Ivabradine Tablets 7.5mg

Abrin

The Searle Company Limited,Pakistan

Morison Limited

Accepted for Review

MSL/89/2023

Ivabradine Tablets 5mg

Abrin

The Searle Company Limited,Pakistan

Morison Limited

Accepted for Review

MSL/90/2023

Bupivacaine Hydrochloride Injection BP 5mg/ml

B cane Heavy

Aculife Healthcare (Pvt) Ltd,India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/91/2023

Paracetamol Infusion 10mg/ml

Acupara

Aculife Healthcare (Pvt) Ltd,India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/92/2023

Ketamine Injection BP 50mg/ml

Ketadol

Aculife Healthcare (Pvt) Ltd,India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/93/2023

Atracurium Besylate Injection USP 10mg/ml

Atracurin

Aculife Healthcare (Pvt) Ltd,India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/94/2023

Rupatadine Tablets 10mg

ZEALARGY

Cadila Pharmaceutical Limited, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/97/2023

Sitagliptin Tablets 50mg

Sitapride - 50

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Rejected

MSL/98/2023

Sitagliptin Tablets 100mg

Sitapride - 100

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Rejected

MSL/99/2023

Tamsulosin Prolonged- Release Tablets 0.4mg

Sutral

Micro Labs Ltd,India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/100/2023

Paracetamol Infusion 10mg/ml

Acupara

Aculife Healthcare (Pvt) Ltd,India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/103/2023

Carvedilol Tablets 12.5mg

N/A

Centurion Laboratories (Pvt) Ltd, India

Yaden International (Pvt) Ltd

Accepted for Review

MSL/104/2023

Losartan Potassium Tablets BP 50mg

NATRASOL 50

Centurion Laboratories (Pvt) Ltd, India

Yaden International (Pvt) Ltd

Accepted for Review

MSL/108/2023

Oxaliplatin for Injection USP 100mg/Vial

BRUOXAL-100

Bruck Pharma (Pvt) Ltd,India

Yaden International (Pvt) Ltd

Accepted for Review

MSL/109/2023

Oxaliplatin for Injection USP 50mg/Vial

BRUOXAL-50

Bruck Pharma (Pvt) Ltd,India

Yaden International (Pvt) Ltd

Accepted for Review

MSL/112/2023

Empagliflozin Tablet 25mg

Emjard 25

Square Pharmaceuticals Ltd,Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/114/2023

Empagliflozin Tablet 10mg

Emjard 10

Square Pharmaceuticals Ltd,Bangladesh

CIC Holdings PLC

Accepted for review

MSL/115/2023

Metoprolol Tartrate (as SR) Tablets 50mg

ETOSORT-XL-50

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/117/2023

Venlafaxine Hydrochloride Extended Release Tablets 75mg

VENISH-SR-75

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/118/2023

Venlafaxine Extended Release Tablet 37.5mg

VENISH SR-37.5

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/119/2023

Cefuroxime for Injection USP 750mg

N/A

Swiss Parenterals Ltd, India

P.T.C Medical (Pvt) Ltd

Rejected

MSL/120/2023

Losartan Pottasium Tablets USP 25mg

EMTAN 25

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Accepted for Review

MSL/121/2023

Gliclazide Tablets 80mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare Lanka Limited

Rejected

MSL/122/2023

Clopidogrel Tablets USP 75mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare Lanka Limited

Rejected

MSL/123/2023

Losartan Pottasium Tablets USP 25mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare Lanka Limited

Rejected

MSL/124/2023

Losartan Potassium Tablets USP 50mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare Lanka Limited

Rejected

MSL/125/2023

Rivaroxaban Tablets 20mg

Rivaxo

Getz Pharma Pvt Ltd, Pakistan

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/127/2023

Rivaroxaban Tablets 15mg

Rivaxo

Getz Pharma Pvt Ltd, Pakistan

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/128/2023

Rivaroxaban Tablets 10mg

Rivaxo

Getz Pharma Pvt Ltd, Pakistan

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/132/2023

Sertraline Tablet USP 50mg

ZOLINE-50

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/133/2023

Chlorpromazine Hydrochloride Tablet 50mg

QUIETAL-50

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/138/2023

Lamotrigine Tablet 25mg

LEMIT-25

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/139/2023

Naltrexone Hydrochloride 50mg Tablet

NALCON-50

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/140/2023

Quetiapine (SR) Tablet 200mg

PSYQUIT-SR-200

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

MSL/576/22

Amlodipine 5mg + Olmesartan Medoxomil 40mg Tablets

Camlosart 5/40

Square Pharmaceuticals Ltd(Pabna Unit) , Bangladesh

CIC Holdings PLC

Rejected

MSL/577/22

Amlodipine 5mg + Olmesartan Medoxomil 20mg Tablets

Camlosart 5/20

Square Pharmaceuticals Ltd (Pabna Unit), Bangladesh

CIC Holdings PLC

Rejected

MSL/648/22

Cefixime Dispersible Tablets USP 100mg

MAHASEF-100

Copmed Pharmaceuticals (Pvt) ltd, India for Mankind Pharma Ltd, India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/760/22

Terbutaline sulphate 1.25mg + Bromhexine HCl 4mg + Guaiphenesin 50mg/5ml syrup

TusQ- X Syrup

Blue Cross Laboratories Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/764/22

Aripiprazole Tablet 2mg

Ariprex 2

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review.

MSL/796/22

Amlodipine Tablets USP 5mg

Angicam

Blue Cross Laboratories Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/828/22

Amlodipine and Valsartan Tablets USP 5mg/160mg

Amlodac - VL 5/160

Cadila Healthcare Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/839/22

Metformin Hydrochloride Sustained Release Tablets 1000mg

Glycomet 1000SR

USV Private Limited, India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/868/22

Atorvastatin Tablets IP 20mg

Atormac 20

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/869/22

Clopidogrel Tablets USP 75mg

Clopi 75

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/911/22

Etoricoxib Tablets 90mg

Tory 90

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/912/22

Etoricoxib Tablets 60mg

Tory 60

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/953/22

Empagliflozin Tablets 25mg

Empamac 25

Macleods Pharmaceuticals Ltd, India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

MSL/954/22

Empagliflozin Tablets 10mg

Empamac 10

Macleods Pharmaceuticals Ltd, India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

MSL/1031/22

Metoprolol Tartrate Tablets BP 100mg

VASTAB-100 TABLETS

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Rejected

MSL/1060/22

Deferasirox Tablets 500mg

CHELOVA 500

Jenphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

Accepted for Review

MSL/1061/22

Deferasirox Tablets 250mg

CHELOVA 250

Jenphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

Accepted for Review

MSL/1065/22

Levothyroxine Sodium Tablets USP 150mcg

Thyrox 150

Macleods Pharmaceuticals Ltd, India

Emerchemie NB Ceylon Limited

Rejected

MSL/1066/22

Levothyroxine Sodium Tablets USP 125mcg

Thyrox 125

Macleods Pharmaceuticals Ltd, India

Emerchemie NB Ceylon Limited

Rejected

MSL/1179/22

Aceclofenac Tablet 100mg

Aceclosun 100

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1180/22

Levofloxacin Tablet USP 500mg

Levosun 500

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1181/22

Ibuprofen Tablet BP 400mg

Iburise 400

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1182/22

Glimepiride Tablet USP 4mg

S Glim 4

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1183/22

Glimepiride Tablet USP 2mg

S Glim 2

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1184/22

Gliclazide Tablets BP 80mg

Rizide

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1185/22

Domperidone Tablet BP 10mg

Vomiavert

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Rejected

MSL/1186/22

Digoxin Tablet BP 0.25mg

Digsun

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1187/22

Diclofenac Gastro-Resistant Tablet BP 50mg

Sunfenac 50

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1188/22

Clomiphene Citrate Tablet USP 50 mg

Clomisun

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1189/22

Clindamycin Lotion BP 10 mg/ml

Clindamycin Lotion

Incepta Pharmaceuticals Ltd, Bangladesh

Citihealth Imports Pvt Ltd

Accepted for Review

MSL/1193/22

Loratadine Tablets 10mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1194/22

Pantoprazole Sodium Tablets 40mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1195/22

Clotrimazole cream BP 1% w/w

Canben Cream

Leben Laboratories Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1196/22

Telmisartan Tablets USP 80mg

Telmac 80

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1197/22

Telmisartan Tablets USP 20mg

Telmac 20

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1198/22

Telmisartan Tablets USP 40mg

Telmac 40

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1199/22

Human anti-D immunoglobulin

IMMUNORHO

Kedrion San't Antimo, Italy

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1200/22

Human anti-D immunoglobulin

IMMUNORHO

Kedrion San't Antimo, Italy

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1202/22

Everolimus Tablet 0.25mg

JOELIMUS 0.25

Jodas Expoim Pvt Ltd, India

Softcare International (Pvt) Ltd

Accepted for Review

MSL/1203/22

Capecitabine Tablets USP 500mg

BRUBINE 500mg

Bruck Pharma Pvt Ltd

Yaden International Pvt Ltd

Accepted for Review

MSL/1204/22

Gemcitabine for Injection USP 200mg

BRUGEM - 200mg

Bruck Pharma Pvt Ltd

Yaden International Pvt Ltd

Accepted for Review

MSL/1205/22

Gemcitabine for Injection USP 1000mg

BRUGEM - 1000mg

Bruck Pharma Pvt Ltd

Yaden International Pvt Ltd

Accepted for Review

MSL/1206/22

Moxifloxacin Hydrochloride Tablets 400mg

Biomox

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for review

MSL/1207/22

Clindamycin Phosphate Cream 2% w/w

C-Mycin

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1208/22

Paroxetine Tablets 25mg

Parxet

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Rejected

MSL/1209/22

Tigecycline for injection 50mg/vial

Tigabio

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1210/22

Ondansetron Injection 8mg/4ml

Vemtix

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1212/22

Memantine Hydrochloride 10mg Tablets

ALZITIN - 10

Consern Pharma Limited, India

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1213/22

Mebendazole 500mg

MEDAZOL TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1214/22

Rabies Antiserum (Lyophilized, Enzyme Refined Equine Immunoglobulin) Lyophilized Powder for Injection 200 IU/ml

Premi-RIG (FD)

Premium Serums & Vaccines Pvt Ltd, India

George Steuart Health (Pvt) Ltd

Accepted for review

MSL/1215/22

Rabies Antiserum (Liquid, Enzyme Refined Equine Immunoglobulin) Injection 200IU/ml

Premi-RIG

Premium Serums & Vaccines Pvt Ltd, India

George Steuart Health (Pvt) Ltd

Accepted for review

MSL/1216/22

Colistimethate Sodium for Injection 1 MIU (Million I.U)

Colicraft

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1217/22

Levodopa 250mg + Carbidopa 25mg Tablets

Bidop

Bio Labs (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1218/22

Ambroxol Hydrochloride 30mg and Guaphenesin 50mg Syrup

Eltuss

Stallion Laboratories (Pvt) Ltd, India

Siba Holdings (Pvt) Ltd

Accepted for Review

MSL/1220/22

Micronized Progesterone Capsules USP 200mg

UTROGEST - 200

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1221/22

Aciclovir Powder for solution for IV Infusion 250mg/vial

VIRACY

Jodas Expoim Pvt Ltd, India

Softcare International (Pvt) Ltd

Accepted for Review

MSL/1222/22

Topiramate Tablet USP 50mg

TRITOP TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1223/22

Tranexamic Acid Capsule JP 500mg

TRANEXAMIC ACID SEMOS CAPSULE

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1224/22

Permethrin Lotion BP 5% w/w

PERMILOT LOTION

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for review

MSL/1225/22

Topiramate Tablet USP 25mg

TRITOP TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1226/22

Bisacodyl Tablet USP 5mg

SEMODIL TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1227/22

Baclofen Tablet USP 10mg

FENCAB TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1228/22

Topiramate Tablets USP 50mg

Tomax

The SchaZoo Pharmaceutical Laboratories (Pvt) Ltd

A.Baur & Co (Pvt) Ltd

Accepted for Review

MSL/1229/22

Topiramate Tablets USP 25mg

Tomax

The SchaZoo Pharmaceutical Laboratories (Pvt) Ltd

A.Baur & Co (Pvt) Ltd

Accepted for Review

MSL/1232/22

Pantoprazole Sodium Delayed Release Tablets USP 40mg

PIKER 40

Indchemie Health Specialities Pvt Ltd, India

Pharma Associates

Rejected

MSL/1233/22

Atorvastatin Calcium Tablets USP 20mg

LIPILES - 20

Indchemie Health Specialities Pvt Ltd, India

Pharma Associates

Rejected

MSL/1234/22

Atorvastatin Calcium Tablets USP 10mg

LIPILES 10

Indchemie Health Specialities Pvt Ltd, India

Pharma Associates

Rejected

MSL/1246/22

Apixaban Tablet 2.5mg

ZILERO 2.5

PharmEvo (Pvt) Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/1247/22

Ifosfamide For Injection 1000mg

ONFOSFA 1000

Bruck Pharma Pvt Ltd

Yaden International Pvt Ltd

Accepted for Review

MSL/1249/22

Oxaliplatin Injection USP 2mg/ml (100mg/ 50ml Vial & 50mg/25ml Vial)

BRUOXAL 100
BRUOXAL 50

Bruck Pharma Pvt Ltd

Yaden International Pvt Ltd

Accepted for Review

MSL/1251/22

Valsartan Tablet USP 160mg

NEDRAS TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1253/22

Valsartan Tablet USP 40mg

NEDRAS TABLET

Semos Pharmaceuticals (Pvt) Ltd, Pakistan

Bio Tech Pharma (Pvt) Ltd

Accepted for Review

MSL/1257/22

Ranolazine Extended Release Tablets 500mg

RANOPLAN 500

Mankind Pharma Ltd, India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for review

MSL/1260/22

Montelukast Tablets BP 10mg

Ventelucast

Incepta Pharmaceuticals Ltd,Bangladesh

Citihealth Imports Pvt Ltd

Accepted for Review

MSL/1261/22

Ketoconazole Cream 2% w/w

Conaz

Atco Laboratories Limited, Pakistan

Morison Limited

Accepted for Review

MSL/1263/22

Hydrocortisone 1% w/w + Clotrimazole 1% w/w Cream

Curezole

Atco Laboratories Limited, Pakistan

Morison Limited

Accepted for Review

MSL/1266/22

Sitagliptin Tablets 100mg

Aglip

Atco Laboratories Limited, Pakistan

Morison Limited

Rejected

MSL/1267/22

Sitagliptin Tablets 50mg

Aglip

Atco Laboratories Limited, Pakistan

Morison Limited

Rejected

MSL/1268/22

Cetrizine Dihydrochloride Syrup USP 5mg/5ml

Ronex

Hilton Pharma Pvt Ltd, Pakistan

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1269/22

Irbesartan Tablets USP 300mg

Irbemac 300

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1270/22

Irbesartan Tablets USP 75mg

Irbemac 75

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1271/22

Irbesartan Tablets USP 150mg

Irbemac 150

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1272/22

Ranibizumab Solution for Injection 10mg/ml

RanizuRel

Reliance Life Science Pvt Ltd, India

ABC Pharma Services (Pvt) Ltd

Accepted for review

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

MSL/320/22

Hydrocortisone Sodium Succinate for Injection BP 100 MG

HYCORT

Swiss Parenterals Limited, India

P.T.C Medical (Pvt) Ltd

Accepted for Review

MSL/321/22

Cloxacilin Sodium For injection 500mg

CLOXA 500

Swiss Parenterals Limited, India

P.T.C Medical (Pvt) Ltd

Accepted for Review

MSL/322/22

Cloxacilin Sodium For injection 250mg

CLOXA 250

Swiss Parenterals Limited, India

P.T.C Medical (Pvt) Ltd

Accepted for Review

MSL/575/22

Olmesartan Medoxomil BP 20mg + Hydrochlorothiazide BP 12.5mg Tablet

Olmecar Plus 20/12.5

Square Pharmaceuticals Ltd(Pabna Unit), Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/621/22

Doxorubicin HCL Solution for Infusion USP 10mg/5mL

DOBIXIN 10

Drug International Ltd, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/622/22

Carboplatin concentrate for solution for infusion BP 450mg/45ml

CARPLATIN 450

Drug International Ltd, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/654/22

Cilnidipine Tablets 10mg

CINEKAR-10

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare Pvt Ltd

Accepted for Review

MSL/659/22

Cilnidipine Tablets 5 mg

CINEKAR-5

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare Pvt Ltd

Accepted for Review

MSL/681/22

Cefuroxime Axetil for Oral Suspension USP 125mg/5ml

ZENOXIM 125

Indchemie Health Specialities Pvt Ltd,India

Pharma Associates

Accepted for Review

MSL/691/22

Irbesartan 150mg and Hydrochlorothiazide 12.5mg Tablets USP

Irbemac H 150

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/692/22

Ticagrelor Tablets 90mg

Ticamac 90

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/693/22

Ezetimibe Tablets USP 10mg

Mac EZ 10

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/694/22

Irbesartan 300mg and Hydrochlorothiazide 12.5mg Tablets USP

Irbemac H 300

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/695/22

Sertraline Tablets BP 25mg

SERLIN-25 Tablets

Bafna Pharmaceuticals Ltd. India

Pharma Associates

Accepted for Review

MSL/696/22

Risperidone Tablets USP 2mg

PERIONE-2 Tablets

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Accepted for Review

MSL/697/22

Olanzapine Orodispersible Tablets BP 10mg

OLAZ-10 OD Tablets

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Accepted for Review

MSL/731/22

Clonidine Tablets BP 100mcg

CLONID-100 mcg Tablets

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Accepted for Review

MSL/749/22

Dactinomycin Injection USP 500mcg

JOCTINO

Jodas Expoim Pvt Ltd, India

Softcare International Pvt Ltd

Accepted for Review

MSL/751/22

Baclofen Tablet USP 10mg

BACLOFEN

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/757/22

Olmesartan Medoxmil USP 20mg & Hydrochlorothiazide USP 12.5mg Tablets

Olemsar H

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/758/22

Amlodipine Besylate Tablets USP 10mg

Amlovas 10

Macleods Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/759/22

Nebivolol Tablets 5mg

Nebimac

Macledos Pharmaceuticals Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/762/22

Salmeterol 25 mcg + Fluticasone propionate 250 mcg MDI

Ticamet 250

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/771/22

Ranolazine Extended Release Tablets 1000mg

Ranoz 1000

Cadila Healthcare Ltd, India

Zydus Lanka (Pvt) Ltd

Accepted for Review

MSL/772/22

Rnolazine Extended Release Tablets 500mg

RANOZ 500

Cadila Healthcare Ltd, India

Zydus Lanka (Pvt) Ltd

Accepted for Review

MSL/773/22

Desonide Cream 0.05%

DESOZY

Cadila Healthcare Ltd, India

Zydus Lanka (Pvt) Ltd

Accepted for Review

MSL/800/22

Silodosin Capsules 4mg

Urydos-4

Micro Labs Limited, India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/801/22

Silodosin Capsules 8mg

Urydos-8

Micro Labs Limited, India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/802/22

Dapagliflozin Tablets 5mg

Dapzin-5

Micro Labs Limited, India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/819/22

Sodium Valproate BP 133.5mg & Valproic Acid USP 58mg Controlled Release Tablets (Controlled Release Tablets of Sodium Valproate & Valproic Acid 200mg )

VALCONTIN 200

Modi Mundipharma (Pvt) Ltd

Robert Hall & Co (Pvt) Ltd

Accepted for Review

MSL/820/22

Sodium Valproate BP 333mg & Valproic Acid USP 145mg Controlled Release Tablets (Controlled Release Tablets of Sodium Valproate & Vaproic Acid 500mg )

VALCONTIN 500

Modi Mundipharma (Pvt) Ltd

Robert Hall & Co (Pvt) Ltd

Accepted for Review

MSL/822/22

Azacitidine for injection 100mg/vial

JODASCITIDINE

Jodas Expoim Pvt Ltd, India

Softcare International Pvt Ltd

Accepted for Review

MSL/830/22

Cilnidipine 5mg Tablets

Cildocal 5

Delta Pharma Limited, Bangladesh

Hyena Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/836/22

Apixaban Tablet 2.5mg

APIXTRA 2.5

Hetero Labs Limited, India

Mansel (Ceylon) Pvt Ltd

Accepted for Review

MSL/838/22

Sodium Valproate and Valproic Acid Controlled Release Tablets 200mg

Valprid - CR 200

Micro Labs Limited, India

Micro Healthcare (Pvt) Ltd

Accepted for Review

MSL/842/22

Streptokinase Injection BP 1500000 IU

STREPTONASE 15

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/843/22

Azathioprine Tablet USP 50mg

THIOPRESS 50

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/844/22

Dopamine Hydrochloride Injection USP 200mg /5mL

DOPRESS 200

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/845/22

Mycophenolate Sodium Tablet 360mg

MYOTEC-S 360

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/846/22

Netilmicin Sulphate Injection USP 100mg/2ml

NETMICIN-100

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/847/22

Aztreonam for Injection USP 1g

AZOM 1.0

United Biotech (P) Ltd, India

Klintas (Pvt) Ltd

Accepted for Review

MSL/848/22

Sacubitril 49mg + Valsartan 51mg Tablets

Vacutro

Getz Pharma (Pvt) Ltd, Pakistan

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/849/22

Sacubitril 24mg + Valsartan 26mg Tablets

Vacutro

Getz Pharma (Pvt) Ltd, Pakistan

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/850/22

Sacubitril 97mg + Valsartan 103mg Tablets

Vacutro

Getz Pharma (Pvt) Ltd, Pakistan

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/859/22

Cloxacillin Sodium for Injection BP 500mg

N/A

Karnataka Antibiotics & Pharmaceuticals Limited, India

A.Baur & Co Pvt

Accepted for Review

MSL/881/22

Abacavir Tablets USP 300mg

Abamune

Cipla Ltd, India

Breathe Free Lanka Pvt ltd

Accepted for Review

MSL/893/22

Povidone Iodine Topical Solution USP 10% w/v, 50ml & 500ml

VIDIN SOLUTION

Zee Laboratories, India

ABC Pharma Services (Pvt) Ltd

Accepted for Review

MSL/895/22

Povidone Iodine Ointment USP 5% w/w

VIDIN OINTMENT

Zee Laboratories, India

ABC Pharma Services (Pvt) Ltd

Accepted for Review

MSL/910/22

Etoricoxib Tablets 120mg

Tory 120

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/913/22

Olanzapine Tablets USP 5mg

Deprex 5

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/914/22

Olanzapine Tablets USP 10mg

Deprex 10

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/915/22

Pregabalin Capsule 50mg

Neurolin 50

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/916/22

Pregabalin Capsules 75mg

Neurolin 75

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/918/22

Deferiprone Tablet 500mg

DEFERA-500

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

MSL/943/22

Phenytoin Tablets BP 50mg

 

Centurion Laboratories Ltd, India

Yaden International

Accepted for Review

MSL/956/22

Cilinidipine 10mg Tablets

Blocdin-10

Finecure Pharmacuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/957/22

Sodium Valproate 200mg /5ml Syrup

SODIVAL Syrup (100ml)

Advanced Chemical Industries Limited, Bangladesh

Amsted Intima (Pvt) Ltd

Accepted for Review

MSL/970/22

Levothyroxine Sodium Tablets USP 25mcg

Thyrox 25

Macleods Pharmaceuticals Ltd, India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

MSL/971/22

Vildagliptin Tablets 50mg

Justeez 50

Emcure Pharmaceuticals Ltd, India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

MSL/972/22

Levothyroxine Sodium Tablets USP 75mg

Thyrox 75

Macleods Pharmaceuticals Ltd, India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

MSL/990/22

Pregabalin Capsules IP 50mg

PREGAB 50

The Madras Pharmaceuticals, India

Pharma Associates

Accepted for Review

MSL/991/22

Prednisolone Sodium Phosphate Oral Solution BP 5mg/5ml

PREDSOL

The Madras Pharmaceuticals, India

Pharma Associates

Accepted for Review

MSL/994/22

Ivabradine Hydrochloride Tablets 5mg

Ivadin 5mg Tablet

Pharmevo Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/995/22

Hydroxocobalamin Injection BP 1mg/ml

 

Mercury Laboratories Limited, India

Yaden International

Accepted for Review

MSL/996/22

Heparin Sodium Injection USP 5000 units/ml

CONPARIN

Concept Pharmaceuticals Ltd, India

Softcare International Pvt Ltd

Accepted for Review

MSL/997/22

Vildagliptin Tablets 50mg

Galvus

Lek Pharmaceuticals d.d, Slovenia

A.Baur & Co Pvt

Accepted for Review

MSL/998/22

Eltrombopag 50mg film-coated Tablet

Revolade

Lek Pharmaceuticals d.d, Slovenia

A.Baur & Co Pvt

Accepted for Review

MSL/1002/22

Mesalamine 400mg Tablets

MESACAM-400

Genome Pharmaceuticals Pvt Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1003/22

Quetiapine Tablet 100mg

Quantia 100

Unison Laboratories Co: Ltd, Thailand

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1004/22

Quetiapine Tablet 200mg

Quantia 200

Unison Laboratories Co: Ltd, Thailand

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1005/22

Quetiapine Tablet 25mg

Quantia 25

Unison Laboratories Co: Ltd, Thailand

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1006/22

Gliclazide Tablets 40mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1007/22

Rosuvastatin Tablets 5mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1008/22

Rosuvastatin Tablets 20mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1009/22

Rosuvastatin Tablets 10mg

 

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Rejected

MSL/1014/22

Bivalent Poliomyelitis Vaccine Type 1 and Type 3, Live (Oral)

 

Panacea Biotec Limited, India

A.Baur & Co Pvt

Accepted for Review

MSL/1015/22

Purified Diphtheria Toxoid, Purified Tetanus Toxoid, Whole Cell Pertussis, Recombinant Hepatitis B, Haemophilus Influenzae type b conjugated and Inactivated Poliomyelitis Trivalent Vaccine (adsorbed)

EasySix

Panacea Biotec Limited, India

A.Baur & Co Pvt

Accepted for Review

MSL/1016/22

Purified Diphtheria Toxoid, Purified Tetanus Toxoid, Whole Cell Pertussis, Recombinant Hepatitis B, Haemophilus Influenzae type b conjugated and Inactivated Poliomyelitis Trivalent
Vaccine (adsorbed)

EasySix

Panacea Biotec Limited, India

A.Baur & Co Pvt

Accepted for Review

MSL/1017/22

Levocetirizine Dihydrochloride Syrup 2.5mg/5ml

1-AL Syrup

FDC Ltd, India

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1018/22

Betahistine Tablets IP 8mg

Vertin 8

Abbott Healthcare Pvt Ltd, India

CIC Holdings PLC

Accepted for Review

MSL/1019/22

Betahistine Tablets IP 16mg

Vertin 16

Abbott Healthcare Pvt Ltd, India

CIC Holdings PLC

Accepted for Review

MSL/1020/22

Betahistine Tablets IP 24mg

Vertin 24

Abbott Healthcare Pvt Ltd, India

CIC Holdings PLC

Accepted for Review

MSL/1021/22

Baclofen Tablets USP 10mg

SPINOBAK-10

Mankind Pharma Ltd, India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1022/22

Imatinib mesylate Tablets 400mg

VEENAT

Natco Pharma Ltd, India

Sunshine Healthcare lanka Limited

Accepted for Review

MSL/1023/22

Human Normal Immunoglobulin 50g/L

Ig VENA

Kedrion S.P.A, Italy

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1024/22

Human Albumin 200g/L

UMAN ALBUMIN

Kedrion S.P.A, Italy

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1025/22

Diphtheria, Tetanus, Pertussis (whole cell), Hepatitis B (rDNA) and Haemophilus Influenzae type b conjugated vaccine (adsorbed) IP

Easyfive-TT

Panacea Biotec Limited, India

A.Baur & Co Pvt

Accepted for Review

MSL/1028/22

Medroxyprogesterone Injection BP 150mg/ml

MEDOGEN Injection

Incepta Pharmaceuticals Ltd, Bangladesh

Citihealth Imports Pvt Ltd

Accepted for Review

MSL/1030/22

Metoprolol Tartrate Tablets BP 25mg

VASTAB-25 TABLETS

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Accepted for Review

MSL/1032/22

Metoprolol Tartrate Tablets BP 50mg

VASTAB-50 TABLETS

Bafna Pharmaceuticals Ltd, India

Pharma Associates

Accepted for Review

MSL/1034/22

Amiodarone Sterile Concentrate BP 150mg/3ml

DURON

Samarth Life Sciences Pvt Ltd, India

Pharma Associates

Accepted for Review

MSL/1035/22

Excitalopram Tablets USP 10mg

ESCIVEX 10

West Cost Pharmaceutical Works Ltd, India

AV Global Impex (Pvt) Ltd

Accepted for Review

MSL/1036/22

Gliclazide Tablets BP 80mg

VEXGID 80

West Cost Pharmaceutical Works Ltd, India

AV Global Impex (Pvt) Ltd

Accepted for Review

MSL/1037/22

Saline Nasal Solution 0.65% w/v

NORLIN

Zen Pharama Pvt Ltd , India

Radiant Healthcare Pvt Ltd

Accepted for Review

MSL/1038/22

Iron Sucrose Injection USP

HEMCROZ

Zen Pharama Pvt Ltd , India

Radiant Healthcare Pvt Ltd

Accepted for Review

MSL/1039/22

Pemetrexed Powder for Concentrate for Solution for Infusion 100mg

Pemetrex venus

Venus Remedies Limited, India

Yaden International Pvt Ltd

Accepted for Review

MSL/1040/22

Levetiracetam Tablet USP 500mg

Lectom 500

Focus and Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1043/22

Pregabalin Capsule 75mg

PinGab 75

Focus and Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Rejected

MSL/1044/22

Pregabalin Capsule 50mg

PinGab 50

Focus and Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Rejected

MSL/1045/22

Levetiracetam Tablets USP 1000mg

Lectom 1000mg

Focus and Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for Review

MSL/1046/22

Solution for haemodialysis/ haemofiltration (Sodium 140mmol/L, Potassium 2mmol/L, Calcium 1.5mmol/L, Magnesium 0.5mmol /L, Chloride 111mmol/L, Bicarbonate 35mmol/L, Glucose 5.55mmol/L)

multiBic ® 2 mmol/L Potassium

Fresenius Medical Care, Germany

Fresenius Medical Care Lanka (Pvt) Ltd

Accepted for Review

MSL/1047/22

Solution for haemodialysis/ haemofiltration (Sodium 140mmol/L, Calcium 1.5mmol/L, Magnesium 0.5mmol/L, Chloride 109mmol /L, Bicarbonate 35mmol/L, Glucose 5.55mmol/L)

multiBic ® potassium free

Fresenius Medical Care, Germany

Fresenius Medical Care Lanka (Pvt) Ltd

Accepted for Review

MSL/1048/22

Solution for haemodialysis/ haemofiltration (Sodium 140mmol/L, Potassium 4mmol/L, Calcium 1.5mmol/L, Magnesium 0.5mmol/L, Chloride 113mmol/L, Bicarbonate 35mmol/L, Glucose 5.55mmol/L)

multiBic ® 4mmol/L Potassium

Fresenius Medical Care, Germany

Fresenius Medical Care Lanka (Pvt) Ltd

Accepted for Review

MSL/1050/22

Itraconazole Capsules 100mg

Itrazole 100

Torrent Pharmaceuticals Ltd, India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/1051/22

Olanzapine Orodispersible Tablets 10mg

Tolanz 10

Torrent Pharmaceuticals Ltd, India

Hemas Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/1052/22

Gastro Resistant Sodium Valproate Tablets BP 100mg

 

Mercury Laboratories Limited, India

Yaden International Pvt Ltd

Accepted for Review

MSL/1053/22

Oxytocin Injection BP 5IU/ml

EVATOCIN

Neon Laboratories Limited, India

Yaden International Pvt Ltd

Accepted for Review

MSL/1054/22

Sodium Stibogluconate Injection BP 10g/100ml

 

Mercury Laboratories Limited, India

Yaden International Pvt Ltd

Accepted for Review

MSL/1055/22

Esomeprazole Tablets 40mg

Esmolac 40

Ajanta Pharma Limited, India

A.Baur & Co (Pvt) Ltd

Rejected

MSL/1056/22

Esomeprazole Tablets 20mg

Esmolac 20

Ajanta Pharma Limited, India

A.Baur & Co (Pvt) Ltd

Rejected

MSL/1057/22

Vildagliptin 50mg and Metformin Hydrochloride 1000mg Tablets

Vildaril M 50/1000

Ajanta Pharma Limited, India

A.Baur & Co (Pvt) Ltd

Accepted for Review

MSL/1058/22

Vildagliptin 50mg and Metformin Hydrochloride 850mg Tablets

Vildaril M 50/850

Ajanta Pharma Limited, India

A.Baur & Co (Pvt) Ltd

Accepted for Review

MSL/1062/22

Levetiracetam Oral Solution USP 100mg/5ml

Lumark

The Searle Company Limited, Pakistan

Morison Limited

Rejected

MSL/1063/22

Levothyroxine Sodium Tablets USP 50mcg

Thyrox 50

Macleods Pharmaceuticals Ltd, India

Emerchemie NB Ceylon Limited

Accepted for Review

MSL/1064/22

Levothyroxine Sodium Tablets USP 100mcg

Thyrox 100

Macleods Pharmaceuticals Ltd, India

Emerchemie NB Ceylon Limited

Accepted for Review

MSL/1068/22

Azithromycin for Oral Suspension USP 200mg/5ml

Zimax Powder for Suspension

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/1070/22

Vildagliptin 50mg + Metformin 850mg Tablet

Galza-met 50/850

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/1071/22

Linagliptin 5mg + Empagliflozin 10mg Tablet

Linjardy 5/10

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/1072/22

Linagliptin 5mg + Empagliflozin 25mg Tablet

Linjardy 5/25

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

MSL/1073/22

Rivaroxaban 15mg Tablets

RIVROXA-15

Genome Pharmaceuticals (Pvt) Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1074/22

Deferiprone 500mg Tablets

RIPRONE-500

Genome Pharmaceuticals (Pvt) Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1075/22

Rivaroxaban 2.5mg Tablets

RIVROXA-2.5

Genome Pharmaceuticals (Pvt) Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1077/22

Rivaroxaban 10mg Tablets

RIVROXA-10

Genome Pharmaceuticals (Pvt) Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1078/22

Atomoxetine (as HCL) 25mg Tablets

ETONIS -25

Genome Pharmaceuticals (Pvt) Ltd, Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1079/22

Betamethasone 0.1% + Neomycin sulphate 0.5% drops

Betabisol-N

ISIS Pharmaceuticals and Chemical Works (Pvt) Ltd, Pakistan

Imperial Life Sciences (Pvt) Ltd

Accepted for Review

MSL/1080/22

Rivaroxaban Film Coated Tablets 2.5mg

RIVAROX 2.5

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1081/22

Rivaroxaban Film Coated Tablets 10mg

RIVAROX 10

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1082/22

Rivaroxaban Film Coated Tablets 15mg

RIVAROX 15

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1083/22

Rivaroxaban Film Coated Tablets 20mg

RIVAROX 20

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1084/22

Levetiracetam Tablets USP 250mg

LEVETAM 250

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1085/22

Levetiracetam Tablets USP 500mg

LEVETAM 500

Eskayef Pharmaceuticals Ltd, Bangladesh

TruVic (Pvt) Ltd

Accepted for Review

MSL/1086/22

Leflunomide Tablet USP 20mg

LUFID 20mg

Swiss Pharmaceuticals (Pvt) Ltd, Pakistan

Talex Pharma (Pvt) Ltd

Accepted for Review

MSL/1087/22

Latanoprost Ophthalmic solution 0.005% w/v

IOPROST EYE DROPS

FDC Limited, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1088/22

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% w/v

OLODIN EYE DROPS

FDC Limited, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1089/22

Carmellose Sodium Eye Drops BP 0.5% w/v

TEARMAX EYE DROPS

FDC Limited, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1090/22

Betahistine Dihydrochloride Tablets BP 8mg

Betastin 8

Corona Remedies Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review

MSL/1091/22

Flunarizine Tablets 5mg

Flumigra 5

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/1092/22

Flunarizine Tablets 10mg

Flumigra 10

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

MSL/1093/22

Clotrimazole Cream BP 1% w/w

CLOTRILIN

Lincoln Pharmaceuticals Ltd, India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1094/22

Gentamicin eye/ear drops 0.3% w/v

L-GENTA

Lincoln Pharmaceuticals Ltd, India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1095/22

Betamethasone Dipropionate Cream USP 0.05% w/w

BET

Lincoln Pharmaceuticals Ltd, India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1096/22

Ketoconazole Cream 2% w/w

KONAZOL

Lincoln Pharmaceuticals Ltd,

 India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1097/22

Clobetasol Cream BP 0.05% w/w

DERMOLIN

Lincoln Pharmaceuticals Ltd,

India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1106/22

Mesna Injection USP 200mg/2ml

JOTEXAN

Jodas Expoim Pvt Ltd, India

Softcare International (Pvt) Ltd

 Accepted for Review

MSL/1107/22

Pegaspargase Injection 3750 IU/5ml (750IU/ml)

Pegasparjo 3750 IU/5ml

Jodas Expoim Pvt Ltd, India

Softcare International (Pvt) Ltd

 Accepted for Review

MSL/1108/22

Termisartan 20mg Tablets

TELMIKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

 Accepted for Review

MSL/1109/22

Termisartan 40mg Tablets

TELMIKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

 Accepted for Review

MSL/1110/22

Termisartan 80mg Tablets

TELMIKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

 Accepted for Review

MSL/1111/22

Rosuvastatin 5mg Tablets

ROSUKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/1112/22

Rosuvastatin 10mg Tablets

ROSUKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/1113/22

Empagliflozin Tablets 10mg

Jardian 10

Beximco Pharmaceuticals Limited, Bangladesh

Emerchemie NB Ceylon Limited

 Accepted for Review

MSL/1114/22

Empagliflozin Tablets 25mg

Jardian 25

Beximco Pharmaceuticals Limited, Bangladesh

Emerchemie NB Ceylon Limited

 Accepted for Review

MSL/1119/22

Prazosin Hydrochloride Extended Release Tablets 5mg

Prazin XL 5mg

The Madras Pharmaceuticals, India

Pharma Associates

 Accepted for Review

MSL/1120/22

Levetiracetam Injection USP 500mg/5ml

Lumark

The Searle Company Limited, Pakistan

Morison Limited

 Accepted for Review

MSL/1121/22

Rivaroxaban Tablets 10mg

RIBAX

Genix Pharma (Pvt) Ltd, Pakistan

Emerchemie NB Ceylon Limited

Accepted for Review

MSL/1122/22

Furosemide Injection BP 10mg/ml

Furasix

Belco Pharma, India

Pharmatec Pvt Ltd

 Accepted for Review

MSL/1123/22

Quetiapine Extended-release Tablets 300mg

SIZONIL XR 300

Saga Lifesciences Limited, India

Zydus Lanka (Pvt) Ltd

Accepted for Review

MSL/1124/22

Anti-human T-Lymphocyte Immunoglobulin (Rabbit)

GRAFALON

Neovii Biotech GmbH, Germany

Zydus Lanka (Pvt) Ltd

Accepted for Review

MSL/1125/22

Telmisartan and Hydrochlorothiazide Tablets 40mg

TEL-OD H

Saga Lifesciences Limited, India

Zydus Lanka (Pvt) Ltd

 Accepted for Review

MSL/1126/22

Quetiapine Extended-release Tablets 200mg

SIZONIL XR 200

Saga Lifesciences Limited, India

Zydus Lanka (Pvt) Ltd

 Accepted for Review

MSL/1127/22

Domperidone Tablet BP 10mg

Almedon 10

Alina Combine Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

 Rejected

MSL/1128/22

Tranexamic acid injection BP 500mg/5ml

Aneptil 500

Alina Combine Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

 Accepted for Review

MSL/1129/22

Aminophylline Ph.Eur.32mg + Diphenhydramine HCI BP 8mg + Ammonium Chloride Ph.Eur 30mg + Menthol BP 0.98mg /5ml Syrup

Aminollin

ISIS Pharmaceuticals and Chemical Works, Pakistan

Imperial Life Sciences (Pvt) Ltd

Rejected

MSL/1130/22

Oral rehydration electrolyte solution (Sodium Chloride BP 1.3g + Trisodium Citrate Dehydrate BP 1.45g + Potassium Chloride BP 0.75g + Glucose anhydrous BP 6.75g )

Novosal

ISIS Pharmaceuticals and Chemical Works, Pakistan

Imperial Life Sciences (Pvt) Ltd

 Accepted for Review

MSL/1131/22

Vitamin B Complex Syrup

Kanavit lysine

ISIS Pharmaceuticals and Chemical Works, Pakistan

Imperial Life Sciences (Pvt) Ltd

 Accepted for Review

MSL/1132/22

Permethrin 5% W/W Cream (50mg/1gm)

Perls Cream

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1133/22

Metronidazole Suspention 200mg/5ml

Micogyl Suspention

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1134/22

Ceftriaxone IV Injection 1gm

Tribac 1gm IV Injection

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1135/22

Octreotide Acetate for Injectable suspention 10mg/vial

OCTEJO LAR 10

Jodas Expoim Pvt Ltd, India

Softcare International (Pvt) Ltd

 Accepted for Review

MSL/1136/22

Rosuvastatin Tablets 20mg

ROSUKE

Finecure Pharmaceuticals Ltd, India

Biolife Pharmaceuticals (Pvt) Ltd

Accepted for Review

MSL/1137/22

Sofosbuvir and Velpatasvir Film Coated Tablets 400mg/100mg

MyHepALL

Mylan Laboratories Limited, India

SMM Halcyon (Pvt) Ltd

  Accepted for Review

MSL/1140/22

Pomalidomide Capsules 4mg

POMALID 4MG

Natco Pharma Limited, India

Sunshine Healthcare Lanka Limited

 Accepted for Review

MSL/1141/22

Pomalidomide Capsules 4mg

POMALID 4MG

Natco Pharma Limited, India

Sunshine Healthcare Lanka Limited

 Accepted for Review

MSL/1142/22

Tamsulosin Hydrochloride Prolonged - release tablet 400mcg

Tamsulosin Sandoz

Lek Pharmaceuticals d.d, Slovenia

A.Baur & Co (Pvt) Ltd

  Accepted for Review

MSL/1144/22

Quetiapine Extended-Release Tablets USP 200mg

Quetemac ER 200

Macleods Pharmaceuticals Ltd, India

Emerchemie NB Ceylon Limited

Accepted for Review

MSL/1145/22

Esomeprazole Tablets 40mg

N/A

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

 Rejected

MSL/1146/22

Esomeprazole Tablets 20mg

N/A

Axon Drugs Pvt Ltd, India

Sunshine Healthcare Lanka Limited

 Rejected

MSL/1147/22

Ticagrelor Tablets, 90mg

TICACARD 90

ARISTOPHARMA LTD, Bangladesh

Hemas Pharmaceuticals (Pvt) Ltd

 Accepted for Review

MSL/1148/22

Montelukast Tablets 5mg

RESPIREL

Candid Pharmaceuticals, Pakistan

Bio Tech Pharma (Pvt) Ltd

 Accepted for Review

MSL/1150/22

Montelukast Tablets 10mg

RESPIREL

Candid Pharmaceuticals, Pakistan

Bio Tech Pharma (Pvt) Ltd

 Accepted for Review

MSL/1152/22

Abiraterone Acetate Tablet USP 250mg

ABIRON-250

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

MSL/1153/22

Olaparib Tablet 150mg

OLAKIN - 150

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

MSL/1154/22

Olaparib Tablet 100mg

OLAKIN - 100

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

MSL/1155/22

Eltrombopag Tablet 50mg

TROMBOLA 50

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

MSL/1156/22

Eltrombopag Tablet 25mg

TROMBOLA 25

Ziska Pharmaceuticals Limited, Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

MSL/1157/22

Methyl Prednisolone Injection 500mg/vial (Powder for Injection)

Mepcort 500 Injection

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1158/22

Methyl Prednisolone Injection 1gm/Vial (Powder for Injection)

Mepcort 1gm Injection

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1163/22

Bisoprolol Fumarate Tablets USP 2.5mg

BRISOTOL 2.5

Fredun Pharmaceuticals Ltd, India

George Steuart Health (Pvt) Ltd

 Accepted for Review

MSL/1164/22

Omalizumab Powder for Solution for Injection 150mg

OmaliRel

Reliance Life Science Pvt Ltd, India

ABC Pharma Services (Pvt) Ltd

 Accepted for Review

MSL/1166/22

Irbesartan 300mg + Hydrochlorothiazide 25mg tablets USP

Arbi-H Tablets 300/25

PharmEvo Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

MSL/1167/22

Irbesartan 300mg + Hydrochlorothiazide 12.5mg Tablets USP

Arbi-H Tablets 300/12.5mg

PharmEvo Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

MSL/1168/22

Irbesartan 150mg + Hydrochlorothiazide 12.5mg Tablets USP

Arbi-H 150/12.5

PharmEvo Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

MSL/1169/22

Moxonidine Tablets BP 0.2mg

Moxilong

Micro Labs Ltd, India

Micro Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1170/22

Moxonidine Tablets BP 0.4mg

Moxilong

Micro Labs Ltd, India

Micro Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1173/22

Tofacitinib Tablets 5mg

Jitrit-5

Micro Labs Ltd, India

Micro Healthcare (Pvt) Ltd

 Accepted for Review

MSL/1175/22

Zinc Sulphate Oral Solution USP 20mg/5ml

Rulozine

Focus and Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

 Accepted for Review

MSL/1174/22

Iron Sucrose Injection USP 100mg

Injectofer Injection

Focus and  Rulz Pharmaceuticals (Pvt) Ltd, Pakistan

Trimed Pharma (Pvt) Ltd

 Accepted for Review

MSL/1176/22

Aspirin Delayed Release Tablets USP 75mg

ASPIPLUS DR-75

Bajaj Healthcare Ltd, India

Chamee Chemist

 Accepted for Review

No

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

       1.             

MSL/595/22

Emulsion for Intravenous Infusion of glucose solution , fat emulsion and amino
acid solution

NuTRIflex Omega Peri

B.Braun Melsungen Ag, Germany

B.Braun Lanka Pvt Ltd

Accepted for Review.

       2.             

MSL/648/22

Cefixime Dispersible Tablets USP 100mg

MAHASEF-100

Copmed Pharmaceuticals (Pvt) ltd, India for Mankind Pharma Ltd,India

Hemas Pharmaceuticals Pvt Ltd

Rejected.

       3.             

MSL/945/22

Divalproex Sodium Extended Release Tablets USP 250mg

Dicorate ER 250

Sun Pharma Laboratories Limited,India

Emerchemie NB (Ceylon) Ltd

Accepted for Review.

       4.             

MSL/987/22

Empagliflozin 12.5mg + Metformin 850mg Tablets

Jardy-met 12.5/850

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review.

       5.             

MSL/988/22

Empagliflozin 5mg + Metformin 850mg Tablets

Jardy-met 5/850

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

       6.             

MSL/941/22

Ivabradine Prolonged Release Tablets 10mg

Pectocare ER 10

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

Rejected.

       7.             

MSL/1041/22

Alfacalcidol Tablets 0.25 mcg

Alcal 0.25

Focus and Rulz Pharmaceuticals (Pvt) Ltd,Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for review

       8.             

MSL/1042/22

Alfacalcidol Tablets 0.50 mcg

Alcal 0.50

Focus and Rulz Pharmaceuticals (Pvt) Ltd,Pakistan

Trimed Pharma (Pvt) Ltd

Accepted for review

       9.             

MSL/1069/22

Amlodipine 5mg + Valsartan 160mg Tablet

Valam 5/160

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for review

No

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

      1.             

MSL/367/22

Baricitinib Tablet 2mg

Barinib 2

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/413/22

Levofloxacin Infusion 500mg / 100ml

LEFEXY IV Infusion

Shrooq Pharmaceuticals Pvt Ltd , Pakistan

Tranz Holding (Pvt) Ltd

Accepted for Review

      3.             

MSL/452/22

Tiotropium Bromide 18mcg + Formoterol fumarate 12mcg + Ciclesonide 400mcg Capsule Powder for Inhalation

TRIMIUM Transcaps

Lupin Limited, India

CIC Holdings PLC

Rejected

      4.             

MSL/518/22

Adapelene EP 0.3% w/w + Benzoyl Peroxide EP 2.5% w/w per Gram Topical Gel

Epiduo Forte

Laboratories Galderma Pvt Ltd, India

Sunshine Healthcare Lanka Limited

Accepted for Review.

 

MSL/552/22

Metformin XR Tablets 500mg

DIARIGHT XR 500 

Novagen Healthcare Pvt Ltd, India

Chamee Chemist

Rejected

      6.             

MSL/593/22

Recombinant Human Interferon Alfa 2b Injection 3 M IU

Bioferon

Biosidus S.A , Argentina

ABC Pharma Services (Pvt) Ltd

Accepted for Review.

 

MSL/623/22

Irinotecan Hydrochloride concentrate for solution for infusion USP 100mg/5ml

IRITA 100

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/624/22

Irinotecan Hydrochloride concentrate for solution for infusion USP 40mg/2ml

IRITA 40

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/625/22

Paclitaxel solution for infusion USP 300mg/50ml

ONTAXEL 300

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/626/22

Paclitaxel solution for Infusion USP 100mg/16.7ml

ONTAXEL 100

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

  11.             

MSL/643/22

Dolutegravir/Lamivudine and Tenofovir Disoproxil Fumarate Tablet 50mg/300mg/300mg

TELDY

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

Accepted for Review

 

MSL/647/22

Cefixime Dispersible Tablets USP 200mg

MAHASEF-200

Copmed Pharmaceuticals (Pvt) ltd, India for Mankind Pharma Ltd,India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/663/22

Cytarabine solution for Injection USP 100mg/2ml

CYTOMIA 100

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/664/22

Paclitaxel solution for infusion USP 30mg/5ml

ONTAXEL 30

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/665/22

Docetaxel solution for infusion USP 80mg/2mL

DAXOTEL 80

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/666/22

Oxaliplatin concentrate for solution for infusion USP 50mg/10ml

OXIPLAT 50

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/667/22

Oxaliplatin concentrate for solution for infusion USP 100mg/20ml

OXIPLAT 100

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/668/22

Daunorubicin solution for infusion USP 20mg/4ml

DORUBIN 20

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

  19.             

MSL/669/22

Ifosfamide USP Injection 2g (Lyophilized powder for injectable solution)

FOSFA

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

  20.             

MSL/670/22

Ifosfamide 1g + Mesna Injection 200mg

JOFAMES

Jodas Expoim Pvt Ltd, India

Softcare International Pvt Ltd

Accepted for Review

 

MSL/745/22

Tamsulosin Hydrochloride Capdule USP 0.4mg

Tamlu

English Pharmaceutical Industries , Pakistan

ABC Pharma Services (Pvt) Ltd

Accepted for Review

 

MSL/766/22

Iron Injection 500mg/10ml (as Ferric carboxymaltose)

Revofer 500IV Injection

Square Pharmaceuticals Ltd,Bangladesh

CIC Holdings PLC

Accepted for Review

  23.             

MSL/767/22

Frusemide Tablets BP 40mg

Frusenem Tablets

Nem Laboratories (Pvt) Ltd

PMS Healthcare (Pvt) Ltd

Accepted for Review

  24.             

MSL/779/22

Carvedilol Tablet XR 10mg

Vediol XR 10

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

Rejected

  25.             

MSL/852/22

Dydrogesterone Tablets USP 10mg

DYDROGEST

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

  26.             

MSL/864/22

Varicella Vaccine powder for injection (Live Varicella Zoster virus>_3.31 g PFS)

 

Changchun Keygen Boilogical Products Co Ltd,China

Ceyoka Pvt Ltd

Accepted for Review.

 

MSL/890/22

Apixaban Tablets 5mg

Advaxaban Tablets 5mg

Martin Dow Marker Ltd, Pakistan

Emerchemie NB (Ceylon) Ltd

Accepted for Review

 

MSL/891/22

Apixaban Tablets 2.5mg

Advaxaban Tablets 20.5mg

Martin Dow Marker Ltd, Pakistan

Emerchemie NB (Ceylon) Ltd

Accepted for Review

 

MSL/924/22

Escitalopram Tablet USP 10mg

Eslopram

The SchaZoo Pharmaceutical Laboratories (Pvt) Ltd,Pakistan

A.Baur & Co Pvt

Rejected

 

MSL/925/22

Meropenem for Injection USP 500mg

Specbac 500mg IV Injection

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

 

MSL/926/22

Meropenem for Injection USP 1gm

Specbac 1mg IV Injection

Square Pharmaceuticals Ltd, Bangladesh

CIC Holdings PLC

Accepted for Review

 

MSL/927/22

Pantoprazole Sodium Delayed-Release Tablet Ph.Eur 20mg

PANDEV 20

Deva Holdings A.S,Turkey

Sheishiki Pharma Pvt Ltd

Rejected

 

MSL/928/22

Montelukast Sodium Tablet 5mg

LUXAT 5

Deva Holdings A.S,Turkey

Sheishiki Pharma Pvt Ltd

Accepted for Review

 

MSL/930/22

Gliclazide Tablets 80mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare lanka Limited

Rejected

 

MSL/931/22

Pegabalin Capsules 75mg

Zeegap

Hilton Pharma (Pvt) Ltd,Pakistan

Sunshine Healthcare lanka Limited

Accepted for Review

 

MSL/932/22

Losartan Potassium Tablets USP 25mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare lanka Limited

Rejected

 

MSL/933/22

Losartan Potassium Tablets USP 50mg

N/A

Axon Drugs Pvt Ltd,India

Sunshine Healthcare lanka Limited

Rejected

 

MSL/934/22

Linezolid Tablets 600mg

LINEGEN 600

Hetero Labs Limited, India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

 

MSL/935/22

Cholecalciferol Chewable Tablets 5000IU

CALMIT 5K

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Rejected

 

MSL/936/22

Losartan Potassium Tablets USP 25mg

EMTAN 25

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Rejected

 

MSL/937/22

Amlodipine Besylate and Atorvastatin Calcium Tablets 5mg/10mg

ATORVA AM 5/10

Cadila Healthcare Ltd,India

Sunshine Healthcare lanka Limited

Rejected

 

MSL/938/22

Tofacitinib Tablets 5mg

TOJAK

Eskayef Pharmaceuticals Limited,Bangladesh

Truvic Pvt Ltd

Accepted for Review

 

MSL/940/22

Loratadine Tablet 10mg

Loraright

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

Rejected

 

MSL/942/22

Carvedilol Tablets XR 5mg

Vediol XR 5

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

Rejected

 

MSL/944/22

Fluoxetine Tablet USP 20mg

Floxac

The SchaZoo Pharmaceutical Laboratories (Pvt) Ltd,Pakistan

A.Baur & Co Pvt

Accepted for Review

 

MSL/946/22

Fusidic Acid Eye Drops BP , 1% w/w

FUSITHAL

ARISTOPHARMA LTD, Bangladesh

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/949/22

Rifaximin 550mg Tablets

RIXMIN-550

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/950/22

Rifaximin 200mg Tablets

RIXMIN-200

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/951/22

Ticagrelor Tablets 90mg

ACS-90 Tablets

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/955/22

Losartan Potassium Tablets USP 50mg

CARDON 50

Eskayef Pharmaceuticals Limited,Bangladesh

Truvic Pvt Ltd

Accepted for Review

 

MSL/959/22

Sodium Fusidate 250mg Tablets

FUGEN-250

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/960/22

Tizanidine Tablets USP 4mg

Tonolyte 4

Unison Laboratories Co: Ltd,Thailand

Sunshine Healthcare lanka Limited

 Accepted for Review

 

MSL/961/22

Tizanidine Tablets USP 2mg

Tonolyte 2

Unison Laboratories Co: Ltd,Thailand

Sunshine Healthcare lanka Limited

 Accepted for Review

 

MSL/962/22

Memantine Hydrochloride Tablets 10mg

Memxa 10

Unison Laboratories Co: Ltd,Thailand

Sunshine Healthcare lanka Limited

Accepted for Review

 

MSL/963/22

Everolimus Tablet 0.25mg

EVERGRAF 0.25

Panacea Biotec Pharma Ltd, India

Markss HLC (Pvt) Ltd

Accepted for Review

 

MSL/964/22

Everolimus Tablet 0.5mg

EVERGRAF 0.5

Panacea Biotec Pharma Ltd, India

Markss HLC (Pvt) Ltd

Accepted for Review

 

MSL/965/22

Co-Trimoxazole Tablet BP 480mg

DIBAC

MMC Healthcare Ltd,India

Markss HLC (Pvt) Ltd

Accepted for Review

 

MSL/966/22

Clopidogrel Tablets USP 75mg

 

Axon Drugs Pvt Ltd,India

Sunshine Healthcare lanka Limited

Rejected

 

MSL/967/22

Cefuroxime Tablets BP 250mg

AXETINE

Medochemie Ltd, Cyprus

George Steuart Health Pvt Ltd

Accepted for Review

 

MSL/968/22

Cefuroxime Tablets BP 500mg

AXETINE

Medochemie Ltd, Cyprus

George Steuart Health Pvt Ltd

Accepted for Review

 

MSL/969/22

Cefixime Tablets USP 200mg

CEFIMED

Medochemie Ltd, Cyprus

George Steuart Health Pvt Ltd

Accepted for Review

 

MSL/973/22

Acalabrutinib Capsules 100mg

CALQUENCE

AstraZeneca AB, Sweden

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/974/22

Donepezil Hydrochloride Tablets USP 10mg

Torpezil 10

Torrent Phamecuticals Ltd,India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

 

MSL/975/22

Lacosamide 100mg Tablets

VIMPEX-100

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/976/22

Ropinirole Hydrochloride 0.25mg Tablets

REOL-0.25

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/977/22

Lacosamide 50mg Tablets

VIMPEX-50

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/978/22

Ropinirole Hydrochloride 2mg Tablets

REOL-2

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/979/22

Lacosamide 200mg Tablets

VIMPEX-200

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/980/22

Ropinirole Hydrochloride 1mg Tablets

REOL-1

Genome Pharmaceuticals Pvt Ltd,Pakistan

Slim Pharmaceuticals Ltd

Accepted for Review

 

MSL/981/22

Bivalent Poliomyelitis (Live) Vaccine Type I Type III, (Oral)

BIOPOLIO B1/3

Bharat Biotech International Ltd, India

Gulf Pharma Pvt Ltd

Accepted for Review

 

MSL/982/22

Bivalent Poliomyelitis (Live) Vaccine Type I Type III, (Oral)

BIOPOLIO B1/3

Bharat Biotech International Ltd, India

Gulf Pharma Pvt Ltd

Accepted for Review

 

MSL/983/22

Sacubitril 49mg + Valsartan 51mg Tablets

Forhef 49/51

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

 

MSL/984/22

Amlodipine 10mg + Valsartan 160mg Tablet

Valam 10/160

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

 

MSL/985/22

Sacubitril 24mg + Valsartan 26mg Tablets

Forhef 24/26

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

 

MSL/986/22

Sacubitril 97mg + Valsartan 103mg Tablets

Forhef 97/103

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

 

MSL/989/22

Amlodipine 5mg + Valsartan 80mg Tablet

Valam 5/80

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

Accepted for Review

 

MSL/992/22

Enzalutamide 40mg Soft Capsules

 

Lotus Pharmaceuticals Co.,Ltd, Taiwan

Pharma Associates

Accepted for Review

 

MSL/993/22

Clindamycin Hydrochloride Capsules USP 300mg

Tidact Capsules 300mg

Y.S.P Industries Sdn Bhd of Lt, Malaysia

Indoscan Pvt Ltd

Accepted for Review

No

Reference Number

Generic name of the medicine

Brand name

Name of the Manufacturer

Name of the Importer

MEC Decision

1.       

MSL/239/22

Vitamin E Capsules 400mg

TOCOSULES

Asoj Soft Caps Pvt Ltd,India

George Steuart Health Pvt Ltd

Rejected

2.       

 MSL/413/22

Levofloxacin Infusion 500mg / 100ml

LEFEXY IV Infusion

Shrooq Pharmaceuticals Pvt Ltd , Pakistan

Tranz Holding (Pvt) Ltd

 Accepted for Review

3.       

MSL/454/22

Indacaterol Maleate 110mcg + Glycopyrronium Bromide 50mcg Capsules, Powder For Inhalation

DuPoBro

Lupin Limited, India

CIC Holdings PLC

Accepted for review.

4.       

MSL/462/22

Ketorolac Tromethamine Tablets USP 10mg

KETORA

Medicon Pharmaceuticals Ltd , Bangladesh

Tranz Pharma Holding Pvt, Ltd

Accepted for review

5.       

MSL/561/22

Ursodeoxycholic Acid Capsules 500mg

URSODE 500

Shrooq Pharmaceuticals Pvt Ltd , Pakistan

Tranz Pharma Holding Pvt, Ltd

Accepted for review

6.       

MSL/568/22

Sitagliptin 50mg+Metformin 850mg Tablet

Inosita Plus 50/850mg Tablet

PharmEvo (Pvt) Ltd,Pakistan

CIC Holdings PLC

 Accepted for Review

7.       

MSL/569/22

Sitagliptin 50mg+ Metformin 500mg Tablet

Inosita Plus 50/500mg Tablet

PharmEvo (Pvt) Ltd,Pakistan

CIC Holdings PLC

 Accepted for Review

8.       

MSL/584/22

Mitomycin for Injection USP 2mg/vial

Jomito

Jodas Expoim Pvt Ltd, India

Softcare International Pvt Ltd

Accepted for review

9.       

MSL/594/22

Sodium Alginate 500mg & Sodium Bicarbinate 267mg Suspension

Vison

Indoco Remedies Ltd, India

Hemas Pharmaceuticals Pvt Ltd

Rejected

10.   

MSL/619/22

Carboplatin BP Injection 150mg

CARPLATIN 150

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

11.   

MSL/632/22

Doxophylline INN Tablets 200mg

Doxiva 200

Nipro JMI Pharma Ltd,Banglsdesh

Imedra Healthcare Pvt Ltd

Rejected

12.   

MSL/633/22

Doxophylline INN Tablets 400mg

Doxiva 400

Nipro JMI Pharma Ltd,Banglsdesh

Imedra Healthcare Pvt Ltd

Rejected

13.   

MSL/634/22

Naproxen BP 500mg & Esomeprazole Magnesium Trihydrate BP equivalent to Esomeprazole 20mg

Nimovo Tablets

Nipro JMI Pharma Ltd,Banglsdesh

Imedra Healthcare Pvt Ltd

Rejected

14.   

MSL/655/22

Metformin Sustained Release Tablets BP 500mg

MEFORIN XR-500

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcate Pvt Ltd

Rejected

15.   

MSL/657/22

Clonazepam Tablet USP 0.5mg

CLONIL-0.5

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcate Pvt Ltd

Accepted for Review

16.   

MSL/658/22

Clonazepam Tablet USP 2mg

CLONIL-2

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcate Pvt Ltd

Accepted for Review

17.   

MSL/661/22

Gliclazide Modified Release Tablet BP 30mg

SUCLEER MR-30

Julphar Bangladesh Ltd,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

Accepted for Review

18.   

MSL/662/22

Dapagliflozin Tablet 5mg

DIALOZIN-5

Julphar Bangladesh Ltd,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

Accepted for Review

19.   

MSL/671/22

Mesna Injection 200mg/2ml

JOTEXAN

Jodas Expoim Pvt Ltd, India

Softcare International Pvt Ltd

Accepted for Review

20.   

MSL/675/22

Palonosetron Tablets 0.5mg

PALOREX

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

Accepted for Review

21.   

MSL/676/22

Sunitinib Capsules 25mg

RESINIB 25

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

Accepted for Review

22.   

MSL/677/22

Vitamin E Capsules USP 600mg

E 600

Gelnova Laboratories (India) Pvt Ltd,India

Tabrane Pharmaceuticals Pvt Ltd

Rejected

23.   

MSL/679/22

Hydroxychloroquine Tablets BP 200mg

Immard 200

Ipca Laboratories Ltd,India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

24.   

MSL/680/22

Deflazacort Tablet 6mg

REFLA-6

Julphar Bangladesh Ltd,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

Accepted for Review

25.   

MSL/682/22

Tizanidine Hydrochloride USP equivalent to Tizanidine 2mg

Relentus

Beximco Pharmaceuticals Ltd, Bangladesh

Emerchemie NB (Ceylon) Ltd

Accepted for Review

26.   

MSL/684/22

Empagliflozin Tablets 10mg

EMGLIF 10

Genix Pharma (Pvt) Ltd,Pakistan

Emerchemie NB (Ceylon) Ltd

Rejected

27.   

MSL/685/22

Empagliflozin Tablets 25mg

EMGLIF 25

Genix Pharma (Pvt) Ltd,Pakistan

Emerchemie NB (Ceylon) Ltd

Rejected

28.   

MSL/686/22

Solifenacin Succinate Tablets 5 mg

SOLIF 5

Genix Pharma (Pvt) Ltd,Pakistan

Emerchemie NB (Ceylon) Ltd

Accepted for Review

29.   

MSL/687/22

Divalproex Sodium Extended Release Tablets USP 500mg

Dicorate ER 500

Sun Pharmaceuticals Iaboratories Limited,India

Emerchemie NB (Ceylon) Ltd

Accepted for Review

30.   

MSL/688/22

Thyroxine Sodium Tablets IP 100mcg

Thyronorm 100

Acme Generics LLP,India

Sunshine Healthcare lanka Limited

Accepted for Review

31.   

MSL/689/22

Thyroxine Sodium Tablets IP 25mcg

Thyronorm 25

Acme Generics LLP,India

Sunshine Healthcare lanka Limited

Accepted for Review

32.   

MSL/690/22

Thyroxine Sodium Tablets IP 50mcg

Thyronorm 50

Acme Generics LLP,India

Sunshine Healthcare lanka Limited

Accepted for Review

33.   

MSL/698/22

Ursodeoxycholic acid tablets BP 300mg

URSOWEL 300

Akums Drugs & Pharmaceuticals Ltd, India

Darley Butler & Co Ltd

Accepted for Review

34.   

MSL/699/22

Ursodeoxycholic acid tablets BP 150mg

URSOWEL 150

Akums Drugs & Pharmaceuticals Ltd, India

Darley Butler & Co Ltd

Accepted for Review

35.   

MSL/700/22

Rosuvastatin Tablets USP 20mg

UNOSAT 20

Akums Drugs & Pharmaceuticals Ltd, India

Darley Butler & Co Ltd

Rejected

36.   

MSL/701/22

Rabeprazole Tablets 20mg

WELRAB 20

Akums Drugs & Pharmaceuticals Ltd,India

Darley Butler & Co Ltd

Accepted for Review

37.   

MSL/702/22

Cyclophosphamide for Injection USP 1000mg

NEOPHOS 1g

Drug International Ltd (Unit-2),Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Accepted for Review

38.   

MSL/703/22

Clindamycin Hydrochloride Capsules USP 300mg

Tidact Capsules 300mg

Y.S.P Industries Sdn Bhd, Malaysiya

Indoscan Pvt Ltd

Accepted for Review

39.   

MSL/704/22

Clarithromycin Film Coadted Tablets USP 500mg

Clarimycin Film Coated Tablets
USP 500mg

Y.S.P Industries Sdn Bhd, Malaysiya

Indoscan Pvt Ltd

Accepted for Review

40.   

MSL/706/22

Betamethasone 0.5mg/g and Salicylic acid 30mg/g Ointment IH

Betacylic Ointment

Y.S.P Industries Sdn Bhd, Malaysiya

Indoscan Pvt Ltd

Accepted for Review

41.   

MSL/708/22

Oxcarbazepine Tablets USP 300mg

FOBIGONE-OX 300mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

42.   

MSL/709/22

Oxcarbazepine Tablets USP 150mg

FOBIGONE-OX 150mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

43.   

MSL/710/22

Sertraline Tablets USP 50mg

SERTOP 50mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

44.   

MSL/711/22

Topiramate Tablets USP 25mg

TOPADAY 25mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

45.   

MSL/712/22

Topiramate Tablets USP 50mg

TOPADAY 50mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review.

46.   

MSL/713/22

Escitalopram Oxalate Tablets USP 10mg

ESOPRAM 10mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Rejected

47.   

MSL/714/22

Mirtazapine Tablets USP 15mg

MIRAZ 15mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

48.   

MSL/715/22

Sertraline Tablets USP 100mg

SERTOP 100mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

49.   

MSL/716/22

Levetiracetam Tablets USP 500mg

LYCETAM 500mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

50.   

MSL/717/22

Escitalopram Oxalate Tablets USP 20mg

ESOPRAM 20mg

Healer's Lab,India

Canoe Medicare (Pvt) Ltd

Accepted for Review

51.   

MSL/718/22

Cefepime for Injection USP 1000mg

TOTASEF-1000

Man Kind Pharma Limited,India

Hemas Pharmaceuticals Pvt Ltd

Accepted for Review

52.   

MSL/724/22

Celecoxib Capsules 100mg

 

Cadila Healthcare Ltd,India

Sunshine Healthcare lanka Limited

Rejected

53.   

MSL/725/22

Celecoxib Capsules 200mg

 

Cadila Healthcare Ltd,India

Sunshine Healthcare lanka Limited

Rejected

54.   

MSL/726/22

Caspofungin Acetate 50mg Powder for Concentrate for Solution for Infusion I.V

CASGLO 50mg

Anfarm Hellas S.A.,Greece

Sunshine Healthcare lanka Limited

 Accepted for Review

55.   

MSL/727/22

Caspofungin Acetate 70mg Powder for Concentrate for Solution for Infusion I.V

CASGLO 70mg

Anfarm Hellas S.A.,Greece

Sunshine Healthcare lanka Limited

 Accepted for Review

56.   

MSL/728/22

Irbesartan 300mg + Hydrochlorothiazide 12.5 Tablets

Arbi-D Tablets 300/12.5mg

PharmEvo (Pvt) Ltd,Pakistan

CIC Holdings PLC

Accepted for Review

57.   

MSL/729/22

Irbesartan 300mg + Hydrochlorothiazide 25mg Tablets

Arbi-D Tablets 300/25mg

PharmEvo (Pvt) Ltd,Pakistan

CIC Holdings PLC

Accepted for Review

58.   

MSL/730/22

Irbesartan 150mg + Hydrochlorothiazide 12.5 Tablets

Arbi-D Tablets 150/12.5mg

PharmEvo (Pvt) Ltd,Pakistan

CIC Holdings PLC

Accepted for Review

59.   

MSL/732/22

Levetiracetam Injection USP 500mg/5ml

Larace

Hilton Pharma (Pvt) Ltd,Pakistan

Sunshine Healthcare lanka Limited

Accepted for Review

60.   

MSL/750/22

Cyclophosphamide for Injection USP 200mg

NEOPHOS 200

Drug International Ltd (Unit-2), Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

61.   

MSL/756/22

Ascorbic Acid Chewable Tablets

Choocee-500

Makjai Laboratories (Pvt) Ltd,India

Siba Holdings (Pvt) Ltd

 Accepted for Review

62.   

MSL/765/22

Pregabalin Capsule 150mg

Gablin 150

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

63.   

MSL/767/22

Pregabalin Tablets BP 40mg

Frusenem Tablets

Nem Laboratories (Pvt) Ltd

PMS Healthcare (Pvt) Ltd

Rejected

64.   

MSL/768/22

Nifedipine Retard 20mg

Nefinem

Nem Laboratories (Pvt) Ltd

PMS Healthcare (Pvt) Ltd

 Accepted for Review

65.   

MSL/769/22

Prednisolone Tablets BP 5mg

Predsone-5

Nem Laboratories (Pvt) Ltd

PMS Healthcare (Pvt) Ltd

 Accepted for Review

66.   

MSL/774/22

Gliclazide MR 60mg

Gliclaright MR

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

67.   

MSL/775/22

Salbutamol Syrup 2mg/5ml

 

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

68.   

MSL/776/22

Bisoprolol Tablets 2.5mg

Bisojaj 2.5

Bajaj Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

69.   

MSL/777/22

Celecoxib Capsules 200mg

CELOXIGEN-200

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Rejected

70.   

MSL/778/22

Gliclazide MR Tablets 30mg

Gliclaright MR 30

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

71.   

MSL/780/22

Theophylline SR Tablets 125mg

Astharight

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

72.   

MSL/781/22

Prazosin Tablets 2.5mg

Prazoright XL

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

73.   

MSL/782/22

Celecoxib Capsules 100mg

CELOXIGEN-100

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Rejected

74.   

MSL/783/22

Prazosin Tablets 5mg

Prazoright XL

Novagen Healthcare Pvt Ltd,India

Chamee Chemist

 Accepted for Review

75.   

MSL/784/22

Fluoxetine Tablets USP 40mg

MENTOL 40mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

76.   

MSL/785/22

Fluoxetine Tablets USP 20mg

MENTOL 20mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

77.   

MSL/786/22

Lamotrigine Dispersible Tablets USP 50mg

LAMO 50mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

78.   

MSL/787/22

Lamotrigine Dispersible Tablets USP 25mg

LAMO 25mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

79.   

MSL/789/22

Mirtazapine Tablets USP 7.5mg

MIRAZ 7.5mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

80.   

MSL/790/22

Levetiracetam Tablets USP 250mg

LYCETAM 250mg

Healers Lab,India

Canoe Medicare (Pvt) Ltd

 Accepted for Review

81.   

MSL/792/22

Betamethasone Valerate BP 0.1% w/w + Neomycin Sulfate USP 0.5% w/w Cream

Bactovate Cream

Julphar Bangladesh Limited,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

82.   

MSL/793/22

Clobetasol Propionate BP 0.05% w/w + Neomycin Sulfate USP 0.5% w/w + Nystatin USP 100 000 Units/g Cream

Clobeon Cream

Julphar Bangladesh Limited,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Rejected

83.   

MSL/794/22

Clobetasol Propionate BP 0.05% w/w Ointment

Clobenate Ointment

Julphar Bangladesh Limited,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

84.   

MSL/795/22

Clobetasol Propionate BP 0.05% w/w Cream

Clobenate Cream

Julphar Bangladesh Limited,Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

85.   

MSL/803/22

Temisartan 40mg + Hydrochlorothiazide 12.5mg

TELMI H

Finecure Pharmacuticals Ltd,India

Biolife Pharmaceuticals (Pvt) Ltd

 Accepted for Review

86.   

MSL/804/22

Deflazacort Tablet 24mg

REFLA-24

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

87.   

MSL/806/22

Irinotecan Hydrochloride Injection USP 40mg/2ml

IRITA 40

Drug International Ltd,Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

88.   

MSL/807/22

Rabies Vaccine BP "Rab" 1ml

Abhayrab 1ml

Human Biological Institute,India

New Arumed (Pvt) Ltd

 Accepted for Review

89.   

MSL/808/22

Irbesartan Tablet 300mg

IRBIGEN 300

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

90.   

MSL/809/22

Irbesartan Tablet 150mg

IRBIGEN 150

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

91.   

MSL/810/22

Aripiprazole Tablet 30mg

ARITERO 30

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

92.   

MSL/811/22

Valganciclovir Tablets 450mg

VALVIR 450

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

93.   

MSL/812/22

Thyroxine Sodium Tablets IP 75mcg

Thyronorm - 75

Acme Generics Pvt Ltd,India

Sunshine Healthcare lanka Limited

 Accepted for Review

94.   

MSL/813/22

Thyroxine Sodium Tablets IP 12.5 mcg

Thyronorm - 12.5

Acme Generics Pvt Ltd,India

Sunshine Healthcare lanka Limited

 Accepted for Review

95.   

MSL/814/22

Vildagliptin Tablets 50mg

GDVILDA-50

GD Laboratories India Pvt Ltd, India

Softlogic Pharmaceuticals Pvt Ltd

 Accepted for Review

96.   

MSL/815/22

Hyosine Butyl bromide Tablets BP 10mg

GSPASM

GD Laboratories India Pvt Ltd, India

Softlogic Pharmaceuticals Pvt Ltd

 Accepted for Review

97.   

MSL/816/22

Salbutamol Tablets BP 4mg

SALBO-4

GD Laboratories India Pvt Ltd, India

Softlogic Pharmaceuticals Pvt Ltd

 Rejected

98.   

MSL/817/22

Diclofenac Diethylamine Menthol, Methyl Salicylate & Linseed oil Gel

DICLO G PLUS

GD Laboratories India Pvt Ltd, India

Softlogic Pharmaceuticals Pvt Ltd

 Rejected

99.   

MSL/818/22

Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride & Chlorpheniramine Maleate Syrup

RELIEF SYP

GD Laboratories India Pvt Ltd, India

Softlogic Pharmaceuticals Pvt Ltd

 Accepted for Review

100.                       

MSL/821/22

Tofacitinib Tablets 5mg

TOFANIB

Globe Pharmaceuticals Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

101.                       

MSL/823/22

Betahistine Dihydrochloride Tablets BP 8mg

Betavert 8

Sun Pharmaceuticals Industries Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

102.                       

MSL/824/22

Betahistine Dihydrochloride Tablets BP 16mg

Betavert 16

Sun Pharmaceuticals Industries Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

103.                       

MSL/825/22

Betahistine Dihydrochloride Tablets BP 24mg

Betavert 24

Sun Pharmaceuticals Industries Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

104.                       

MSL/826/22

Isotretinoin Capsules USP 20mg

Sotret 20

Sun Pharmaceuticals Industries Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

105.                       

MSL/827/22

Isotretinoin Capsules USP 10mg

Sotret 10

Sun Pharmaceuticals Industries Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

106.                       

MSL/829/22

Liposomal Amphotericin B for Injection USP 50mg

GUFISOME

Gufic Biosciences Ltd, India

Slim Pharmaceuticals Ltd

 Accepted for Review

107.                       

MSL/831/22

Dapoxetine Hydrochloride INN

EJALONG 60 TABLET

Drug International Limited,Bangladesh

Tropical Pharma (Pvt) Ltd

 Accepted for Review

108.                       

MSL/832/22

Dapoxetine Hydrochloride INN

EJALONG 30 TABLET

Drug International Limited,Bangladesh

Tropical Pharma (Pvt) Ltd

 Accepted for Review

109.                       

MSL/833/22

Silodosin INN Capsules 8mg

SILOFAST-8 Capsule

Drug International Limited,Bangladesh

Tropical Pharma (Pvt) Ltd

 Accepted for Review

110.                       

MSL/834/22

Silodosin INN Capsules 4mg

SILOFAST-4 Capsules

Drug International Limited,Bangladesh

Tropical Pharma (Pvt) Ltd

 Accepted for Review

111.                       

MSL/835/22

Piracetam BP Tablet 800mg

D-PIRA Tablet

Drug International Limited,Bangladesh

Tropical Pharma (Pvt) Ltd

 Accepted for Review

112.                       

MSL/837/22

Brinzolamide Ophthalmic Suspension IP 1% W/v

Brinzagan

Piramal Pharma Limited,India

Hemas Pharmaceuticals Pvt Ltd

 Accepted for Review

113.                       

MSL/840/22

Bisoprolol Tablets 2.5mg

TENOBIS

Drug International Ltd,Bangladesh

Amsted Intima (Pvt) Lrd

 Accepted for Review

114.                       

MSL/841/22

Co-Amoxiclav Oral Suspension BP 156.25mg

DAMOCLAV DRY SYRUP

Saga Lifesciences Limited,India

Klintas (Pvt) Ltd

 Rejected

115.                       

MSL/851/22

Clonazepam Tablet BP 2mg

XYCLON-2

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

116.                       

MSL/853/22

Ethinylestradiol BP 0.02mg + Drospirenone BP 3mg Tablet

NOVULET

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

117.                       

MSL/854/22

Dexamethasone Injection USP 5mg/ml

DEXTASONE

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

Rejected.

118.                       

MSL/856/22

Erythropoietin Injection BP 2000 IU/0.2ml

Epomax 2000

Drug International Ltd (Unit-2), Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

119.                       

MSL/857/22

Clonazepam Tablet BP 0.5mg

XYCLON-0.5

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Pvt Ltd

 Accepted for Review

120.                       

MSL/861/22

Amlodipine Besylate Tablet 5mg

Vazkor 5mg

Deva Holdings A.S,Turkey

Sheishiki Pharma Pvt Ltd

 Accepted for Review

121.                       

MSL/862/22

Amlodipine Besylate Tablet 10mg

Vazkor 10mg

Deva Holdings A.S,Turkey

Sheishiki Pharma Pvt Ltd

 Accepted for Review

122.                       

MSL/863/22

Erythropoietin Injection BP 5000 IU/0.5ml

Epomax 5000

Drug International (Unit-2), Bangladesh

Tabrane Pharmaceuticals (Pvt) Ltd

 Accepted for Review

123.                       

MSL/865/22

Paracetamol I.V Infusion 1g /100ml

FEVASTIN I.V

Tablet (India) Ltd, India for TIL Healthcare Pvt Ltd, India

George Steuart Health Pvt Ltd

 Accepted for Review

124.                       

MSL/866/22

Rivastigmine Capsules 1.5mg

Rivadem 1.5

Torrent Pharmaceuticals Ltd,India

Hemas Pharmaceuticals Pvt Ltd

 Accepted for Review

125.                       

MSL/867/22

Rivastigmine Capsules 3mg

Rivadem 3

Torrent Phamecuticals Ltd,India

Hemas Pharmaceuticals Pvt Ltd

 Accepted for Review

126.                       

MSL/870/22

Aripiprazole Tablets 5mg

ARITERO 5

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

127.                       

MSL/871/22

Aripiprazole Tablet 15mg

ARITERO 15

Hetero Labs Limited,India

Mansel (Ceylon) Pvt Ltd

 Accepted for Review

128.                       

MSL/872/22

Sodium Bicarbonate, Sodium Citrate, Anhydrous Citric acid & Tartaric acid Effervescent granules

AORAL

Akums Drugs & Pharmaceuticals Ltd,India

Darley Butler & Co Ltd

 Rejected

129.                       

MSL/873/22

Dapagliflozin Tablets 5mg

Invaflozin 5

Inventia Healthcare Limited,India

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

130.                       

MSL/874/22

Telmisartan 40mg Tablets

TELGIO 40mg

PT Dexa Medica, Indonesia

A.Baur & Co Pvt

Accepted for Review

131.                       

MSL/875/22

Telmisartan 80mg Tablets

TELGIO 80

PT Dexa Medica, Indonesia

A.Baur & Co Pvt

 Accepted for Review

132.                       

MSL/876/22

Azacitidine for injection 100mg/vial

AZAPAN

Panacea Biotec Pharma Ltd

Markss HLC (Pvt) Ltd

 Accepted for Review

133.                       

MSL/878/22

Escitalopram Tablets USP 20mg

Exapro 20

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

134.                       

MSL/879/22

Escitalopram Tablets USP 10mg

Exapro 10

CCL Pharmaceuticals Pvt Ltd, Pakistan

CIC Holdings PLC

 Accepted for Review

135.                       

MSL/880/22

Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell) , Oral

 

Beijing Institute of Biological Products Co,Ltd, P.R China

Ceyoka Pvt Ltd

 Accepted for Review

136.                       

MSL/882/22

Esomeprazole Tablet 40mg

Esozole 40

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

 Accepted for Review

137.                       

MSL/883/22

Esomeprazole Tablet 20mg

Esozole 20

Sunrise International Labs Limited, India

Zyrex Pharmaceuticals Pvt Ltd

 Accepted for Review

138.                       

MSL/884/22

Metformin Tablet BP 500mg

Glumet

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talax Pharma (Pvt) Ltd

 Rejected

139.                       

MSL/885/22

Tizanidine Tablet USP 4mg

Ezidin 4mg

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talax Pharma (Pvt) Ltd

 Accepted for Review

140.                       

MSL/886/22

Tizanidine Tablets USP 2mg

Ezidin 2mg

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talax Pharma (Pvt) Ltd

 Accepted for Review

141.                       

MSL/887/22

Gastro-Resistant Omeprazole Capsule BP 20mg

SANAMIDOL

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talax Pharma (Pvt) Ltd

 Accepted for Review

142.                       

MSL/888/22

Dapagliflozin Tablet 5mg

QUISHA 5mg

Helix Pharma (Pvt) Ltd, Pakistan

Hemka Pharma (Pvt) Ltd

 Accepted for Review

143.                       

MSL/889/22

Dapagliflozin Tablet 10mg

QUISHA 10mg

Helix Pharma (Pvt) Ltd, Pakistan

Hemka Pharma (Pvt) Ltd

 Accepted for Review

144.                       

MSL/892/22

Sulphasalazine EC Tablets 500mg

SALAZODINE EC

Ferozsons Laboratories Limited,Pakistan

Emerchemie NB (Ceylon) Ltd

 Accepted for Review

145.                       

MSL/894/22

Orlistat Capsule USP 120mg

Orlistar

English Pharmaceutical Industries , Pakistan

ABC Pharma Services (Pvt) Ltd

 Accepted for Review

146.                       

MSL/896/22

Lenvatinib Capsule 4mg

LENVAKIN 4

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Ltd

 Accepted for Review

147.                       

MSL/899/22

Palbociclib Capsules 125mg

PALBOKIN-125

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Ltd

 Accepted for Review

148.                       

MSL/900/22

Osimertinib Tablet 80mg

OSIKIN-80

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Ltd

 Accepted for Review

149.                       

MSL/901/22

Lenvatinib Capsule 10mg

LENVAKIN 10

Ziska Pharmaceuticals Ltd , Bangladesh

Tabrane Pharmaceuticals Ltd

 Accepted for Review

150.                       

MSL/902/22

Ondansetron Tablet USP 4mg

Vomfran Tablet 4mg

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talex Pharma (Pvt) Ltd

 Accepted for Review

151.                       

MSL/903/22

Ondansetron Oral Solution USP 4mg/5ml

Vomfran Syrup

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talex Pharma (Pvt) Ltd

 Accepted for Review

152.                       

MSL/904/22

Ondansetron Injection USP 8mg/4ml

Vomfran Injection

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talex Pharma (Pvt) Ltd

 Accepted for Review

153.                       

MSL/905/22

Leflunomide Tablet BP 10mg

LUFID 10mg

Swiss Pharmaceuticals (Pvt) Ltd,Pakistan

Talex Pharma (Pvt) Ltd

 Accepted for Review

154.                       

MSL/906/22

Vitamin D3 Tablet 25mcg (1000IU)

Sunny D Tablets

Scotmann Pharmaceuticals, Pakistan

Slim Pharmaceuticals Ltd

 Accepted for Review

155.                       

MSL/907/22

Mometasone Furoate 0.1% Lotion

MOMECON 0.1% Lotion

Bilim iLac San. ve Tic,A.S, Turkey

Slim Pharmaceuticals Ltd

 Accepted for Review

156.                       

MSL/908/22

Mometasone Furoate 0.05% Nasal Spray

MOMECON 0.05% Nasal Spray

Bilim iLac San.ve Tic,A.S,Turkey

Slim Pharmaceuticals Ltd

 Accepted for Review

157.                       

MSL/909/22

Ezetimibe Tablet USP 10mg

ZEETA

English Pharmaceutical Industries , Pakistan

ABC Pharma Services (Pvt) Ltd

 Accepted for Review

158.                       

MSL/917/22

Oral Rehydration Salts BP 21.8g (Each sachet contains NaCl BP 2.60g, KCl BP 1.50g,Sodium Citrate BP 2.90g, Anhydrous Glucose BP 13.50g, Excipients q.s.)

ELECTRAL

FDC Ltd,India

Sunshine Healthcare lanka Limited

 Accepted for Review

159.                       

MSL/920/22

Deflazacort Oral Suspension 6mg/5ml

REFLA SUSPENSION

Julphar Bangladesh Ltd, Bangladesh

Tabrane Healthcare (Pvt.) Ltd

 Accepted for Review

160.                       

MSL/922/22

Insulin Injection IP Soluble Human (Recombinant DNA Origin ) 100IU/1ml

Insugen R

Biocon Biologics Limited,India

Morison Ltd

 Accepted for Review

161.                       

MSL/921/22

Gastro-Resistant Sodium Valproate Tablets BP 200mg

VALSTAL-200

Stallion Laboratories (Pvt) Ltd, India

Siba Holdings (Pvt) Ltd

 Accepted for Review

162.                       

MSL/923/22

Fluticasone Furoate Nasal Spray 27.5mcg/Spray

AVAMYS

GlaxoWellcome S.A,Spain

GlaxoSmithKline Pharmaceuticals (Pvt) Ltd

 Accepted for Review

Serial
No 
NMRA NC E-NMRA Number
(If Available )
Name of the Product Manufacturer Local Agent Price (per tablets/capsule/Vial/ampoule) MEC Decision
1 NMRA/EG/DRS/04/2021 Not Applied
via e-nmra
Ivermectin tablets 12mg( Imectin 12) Pulse Pharmaceuticals
 Pvt Ltd India 
George Steuart Health
 Pvt Ltd 
32.00LKR Accepted
2 NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
L-Ornithine L- Aspartate Injection
    5mg/10ml
Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd  470.00LKR Accepted as this produt is used for peadiatric population
  NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
Ceftriaxone Injection 500mg Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd  275.00LKR Accepted
  NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
Verapamil HCL Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd  3750.00LKR Accepted
  NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
Amikacin Injection 500mg  Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd   200.00LKR Accepted
  NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
Mitomycin Injection 2mg Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd  1000.00LKR Accepted
  NMRA/EG/DRS/06/2021 Not Applied
via e-nmra
Amikacin Injection 250mg Health Biotech Ltd India  Orexo Bio Pharma Pvt Ltd  30.00LKR Accepted
3 NMRA/EG/DRS/10/2021
 (Attached Procument Notice)
Not Applied
via e-nmra
Solution For Peritoneal Dialysis Fresenius Medical Care
 Production SDN Malaysia
Fresenius Medical Care
Lanka Pvt Ltd 
1050.00LKR Accepted
4 NMRA/EG/DRS/11/2021 SILMD/2021/02026 Diazepam - Solution for Injection
5mg/ml
Jointa Stock Company
 Latvia 
Baur Life Sciences Pvt Ltd  650.00LKR Accepted
5 NMRA/EG/DRS/12/2021 SILMD/2021/01984
      
Cholecalciferol (DVIT 1000) The Acme Laboratories Ltd Bangladesh Mega Pharma Pvt Ltd   22.00LKR Accepted
  NMRA/EG/DRS/12/2021 SILMD/2021/02141
    
Cholecalciferol (DVIT 2000) The Acme Laboratories Ltd Bangladesh Mega Pharma Pvt Ltd   31.00LKR Accepted
6 NMRA/EG/DRS/09/2021 SILMD/2021/02141
   
Ganciclovir Powder for Concentrate
 for Solution for Infusion 500mg 
Hainan Poly Pharm Co. Ltd China  Yaden International
Pvt Ltd 
8500.00LKR Pending
  NMRA/EG/DRS/09/2021 SILMD/2021/01984
    Paid
 Entecavir Tablets USP 0.5mg Mercury Laboratories Ltd
 India 
Yaden International
Pvt Ltd 
1 Tablet - 1500.00LKR Pending
  NMRA/EG/DRS/09/2021 SILMD/2021/01989
    
Paracetamol Suppository BP 125mg Opsonin Pharma Ltd India Yaden International
Pvt Ltd 
1 Tablet- 135.00LKR Accepted
  NMRA/EG/DRS/09/2021 SILMD/2021/02020
  
 pemetrexed powder for
  Concentrate for solution for Infusion    100mg
Venus Remedies Ltd
India 
Yaden International
Pvt Ltd 
1 Vial - 4100.))LKR Pending
7 NMRA/EG/DRS/18/2021           SILMD/2021/02184 Budesonide Inhalation Suspension
1mg/2ml(Budecort 1mg Respules)
Cipla Ltd India  Breathe Free Lanka Pvt
Ltd 
1 Respule - 150.00LKR Accepted
8 NMRA/EG/DRS/21/2021
New application
SILMD/2021/02529 Colecalciferol Tablets BP 2000 IU
(D-Star 2000)
Nipro JMI Pharma Ltd
Bangladesh 
Imedra Healthcare Pvt
Ltd 
1 Tablet - 35.00LKR Accepted
9 NMRA/EG/DRS/22/2021
(File 2)
SILMD/2021/02206 Viatamin C 500mg Chewable Tablet Innova Captab Pvt Ltd
 India 
Slim Pharmaceuticals
 Pvt Ltd 
1 Tablet- 14.00LKR Accepted
10 NMRA/EG/DRS/22/2021
(File 1)
Not Applied               via e-nmra Vitamin D3 5mg/ml Injection  Scotman Pharmaceuticals
 Pakistan
Slim Pharmaceiuticals
Pvt Ltd 
1 Vial - 320.00LKR Rejected (Previous MEC dicision)
  NMRA/EG/DRS/22/2021 Not Applied                    via e-nmra Vitamin D3 1000 IU/ 10ml Syrup
( Sunny D Absorba Liquid)
Scotman Pharmaceuticals
 Pakistan
Slim Pharmaceiuticals
Pvt Ltd 
120ml Bottle - 310.00LKR Accepted
11 NMRA/EG/DRS/17/2021 SILMD/2021/02219 Metoprolol Succinate Prolonged
   Release Tablets IP 50mg
   (Metozaar XL 50)
Corona Remedies Pvt Ltd
India 
Sunshine Healthcare
 Lanka Ltd 
1 Tablet - 10.30LKR Accepted
  NMRA/EG/DRS/17/2021 SILMD/2021/01939 Betahistine Dihydrochloride Tablets BP 16mg (Betastin16)  Corona Remedies Pvt Ltd
India 
Sunshine Healthcare
 Lanka Ltd 
1 Tablet - 9.433LKR Pending
  NMRA/EG/DRS/17/2021 SILMD/2021/02220 Metoprolol Succinate Prolonged
    Release Tablets IP 25mg (Metozaar
    XL 25) 
Corona Remedies Pvt Ltd
India 
Sunshine Healthcare
 Lanka Ltd 
1 Tablet - 9.36LKR Accepted
12
NMRA/EG/DRS/20/2021
SILMD/2020/01396 Ascorbic Acid Chewable Tablets
500mg 
Stallion Laboratories Pvt Ltd India  Siba Holdings Pvt Ltd  1 Tablet - 15.00LKR Accepted
13 NMRA/EG/DRS/19/2021
 
SILMD/2021/02226 Enoxaparin Sodium Injection USP
60mg 
Jodas Expoim (Pvt) Ltd -
 India 
Softcare International
Pvt Ltd 
1 Injection- 1490.00LKR Accepted
14 NMRA/EG/DRS/27/2021 SILMD/2021/02329 Duloxetine HCZ Capsule USP 30mg Pharmevo Pvt Ltd Pakistan CIC Holdings PLC 1 Tablet - 40.00LKR Accepted
  NMRA/EG/DRS/27/2021 SILMD/2021/02330 Duloxetine HCI Capsules USP 60mg Pharmevo Pvt Ltd Pakistan CIC Holdings PLC 1 Tablet - 70.00LKR Accepted
  NMRA/EG/DRS/27/2021 SILMD/2021/02331 Duloxetine HCI Capsules USP 20mg Pharmevo Pvt Ltd Pakistan CIC Holdings PLC 1 Tablet - 21.00LKR Accepted
15 NMRA/EG/DRS/26/2021 SILMD/2021/01862 Clotrimazole 1% w/w + Hydrocortisone
 % w/w Cream ( Zohydro Cream ) 
Tabros Pharma Pvt Ltd
Pakistan
Associated Laboratories 10g Tube - 224.00LKR Accepted
16 NMRA/EG/DRS/28/2021 SILMD/2021/00041 1.Pantoprazole Gastro Resistant
Tablets 20mg
Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd  Pantin 1 Tablet- 18.00LKR Not Accepted
  NMRA/EG/DRS/28/2021 SILMD/2021/01704 Sitagliptin Film Coated Tablets
 100mg
Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd  Sitazit 1 Tablet- 40.50LKR Not Accepted
  NMRA/EG/DRS/28/2021 SILMD/2021/00043 Pantoprazole Gastro Resistant Tablets 40mg Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd  Pantin 40 - 1 Tablet 30.00
LKR 
Not Accepted
  NMRA/EG/DRS/28/2021 SILMD/2021/01926 Lenalidomide Capsule 15mg Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd  1 Capsule - 1275.00LKR Accepted
  NMRA/EG/DRS/28/2021 SILMD/2021/02465 Linagliptin Tablets 5mg Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd  LINESTA 5 - 1 Tablet-64.00 LKR Not Accepted
  NMRA/EG/DRS/28/2021 SILMD/2021/01924 Lenalidomide Capsule 5mg Hetro Labs Ltd India  Mansel Ceylon Pvt Ltd 
  LINADEX 5 - 1 Capsule -550.00LKR
Accepted
17 NMRA/EG/DRS/25/2021 Not Applied
via e-nmra
Rotavirus Vaccine (Live Oral ) BP Bharata Biotech International
Ltd India 
Gulf Pharma  1. 0.5ml /Vial - 4200.00LKR
2. 2.5ml/ Vial-13125.00LKR
Pending
  NMRA/EG/DRS/25/2021 Not Applied
via e-nmra
Typhoid Vi Conjugated Vaccine
( Typbar TCV)
Bharata Biotech International
Ltd India 
Gulf Pharma  1. 0.5ml-/Vial-8400.00LKR
2. 2.5ml/Vial 31500.00LKR
Pending
18 NMRA/EG/DRS/16/2021 SILMD/2021/02469 Vitamin D tablet 1000 IU Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet - 20.00LKR Accepted
  NMRA/EG/DRS/16/2021 SILMD/2021/02471 Vitamin D tablet BP 5000 IU Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet - 35.00LKR Accepted
  NMRA/EG/DRS/16/2021 SILMD/2021/02479 Vitamin C tablet BP 100mg Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet -15.00LKR Accepted
  NMRA/EG/DRS/16/2021 SILMD/2021/02472 Vitamin D tablet BP 60000 IU  Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet - 75.00LKR Accepted
  NMRA/EG/DRS/16/2021 SILMD/2021/02470 Vitamin D Tablet 2000 IU  Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet- 23.00LKR Accepted
  NMRA/EG/DRS/16/2021 SILMD/2021/02480 Vitamin C Tablets 500mg Mc.W Healthcare Pvt Ltd
India 
Innogen Lanka Pvt LTd 1 Tablet - 3.00LKR Accepted
19 NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Etoricoxib Tablets 90mg Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1 Tablet- 430.00LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Sitagliptin Tablets USP 50 mg Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1Tablet-43.33LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Glimepiride Tablets IP 1mg Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1Tablet-8.15LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Glimepiride Tablets IP 2mg Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1Tablet11.60LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Clobazam Tablet IP 10mg  Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1Tablet10.087LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Glimepiride Tablets IP 3mg  Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1Tablet 19.45LKR Accepted- Site change
  NMRA/EG/DRS/15/2021 Previously Reg.
(Site Changed)
Vidagliptin Tablets 50mg Ajanta Pharma Ltd  India A.Baur& Co. Pvt Ltd  1tablet--50.00LKR Accepted- Site change
20 NMRA/EG/DRS/14/2021 SILMD/2021/01885 Levetiracetam tablet USP 1000mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 6464.00LKR (10x10) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02254 Daclatasvir Tablets 30mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 14193.00LKR
30'Spack
    Bottle Pack 14319.00LKR 28'S Pack
Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02100 Tranexamic Acid Tablets BP 500 mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 1568.00LKR( 3x10 ) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/01894 Donepezil Hydrochloride  Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 1598.00LKR( 2x10)
Blister Pack 7992.00LKR ( 10x10)
Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02404 Sitagliptin Tablets USP 25mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 858.00LKR(50s) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02450 Lamotrigine Extended Release Tablets 100 mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 699.00LKR(30s) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02451 Lamotrigine Extended Release Tablets 200 mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 1182.00LKR(30s) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02406 Sitagliptin Tablets USP 100mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 2774.00LKR (50s) Pending
  NMRA/EG/DRS/14/2021 SILMD/2021/01361 Lamotrigine Extended Release Tablets 50 mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 399.00LKR(30s) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02405 Sitagliptin Tablets USP 50mg Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd  Blister Pack 1630.00LKR(50s) Accepted
  NMRA/EG/DRS/14/2021 SILMD/2021/02101 Pramipexole Dihydrochloride Tablets
0.250mg
Cadila Healthcare Limited
 India 
Zydus Lanka Pvt Ltd 
3x10 Blister Pack -616.00LKR
   10x10 Blister Pack -1898.00LKR
Accepted

Reference No Generic Name Brand Name Manufacturer Name Country Local Agent  MEC Decision
SILMD/2021/02404 Lamotrigine Extended Release Tablets 50mg LAMIDUS ER 50 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02405 Lamotrigine Extended Release Tablets 100mg LAMIDUS ER 100 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02406 Lamotrigine Extended Release Tablets 200mg LAMIDUS ER 200 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02407 Enoxaparin Sodium Injection USP 40mg/0.4ml    Changzhou Qianhong Bio-pharma Co., Ltd. China Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02408 Enoxaparin Sodium Injection USP 60mg/0.6ml    Changzhou Qianhong Bio-pharma Co., Ltd. China Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02409 Doxorubicin Hydrochloride Liposome Injection 2mg/ml   CSPC OUYI Pharmaceutical Co.Ltd China Ceyoka(Pvt)Ltd Accepted
SILMD/2021/02410 Octreotide Injection 0.05 mg/ml OCTEJO 0.05 Jodas Expoim Pvt Ltd India Softcare International (Pvt) Ltd Accepted
SILMD/2021/02411 Octreotide Injection 0.1mg/ml OCTEJO 0.1 Jodas Expoim Pvt Ltd India Softcare International (Pvt) Ltd Accepted
SILMD/2021/02412 Octreotide for Injectable Suspension 10mg  OCTEJO LAR 10 Jodas Expoim Pvt Ltd India Softcare International (Pvt) Ltd Accepted
SILMD/2021/02413 Octreotide for Injectable Suspension 20mg OCTEJO LAR 20 Jodas Expoim Pvt Ltd India Softcare International (Pvt) Ltd Accepted
SILMD/2021/02414 Octreotide for Injectable Suspension 30mg  OCTEJO LAR 30 Jodas Expoim Pvt Ltd India Softcare International (Pvt) Ltd Accepted
SILMD/2021/02415 Levetiracetam Injection 500mg/5ml  Lerace Injection 500mg/5ml  Hilton Pharma Private Limited Pakistan Sunshine Healthcare Lanka Limited  Accepted
SILMD/2021/02416 Fenofibrate Capsules 200mg Fenocor Ordain Healthcare Global Private Limited India SIBA HOLDINGS PVT LTD Accepted
SILMD/2021/02417 Nicorandil Tablet BP 10mg Poten Ordain Healthcare Global Private Limited India SIBA HOLDINGS PVT LTD Accepted
SILMD/2021/02418 Sycazine 5 Sycazine 5 XL Laboratories (Pvt) Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02419 Osimertinib Film Coated Tablet 80mg Tagrisso AstraZeneca AB Sweden Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02420 Leflunomide Tablet (film coated) USP 20 mg  Lefra - 20 Torrent Pharmaceuticals Ltd India Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02421 Vitamin E Capsules USP 400mg TOCOSULES ASOJ SOFT CAPS PVT. LTD India George Steuart Health (Pvt.) Ltd Accepted
SILMD/2021/02422 Clopidogrel Tablets USP 75mg CLOPITIL TIL Healthcare Pvt Ltd India George Steuart Health (Pvt.) Ltd Rejected 
SILMD/2021/02423 Metformin Tablets BP 500mg TILFORMIN TIL Healthcare Pvt Ltd India George Steuart Health (Pvt.) Ltd Rejected 
SILMD/2021/02424  Tiotropium Powder for Inhalation IP Tiate Transcaps Lupin Limited India CIC Holdings PLC Accepted
SILMD/2021/02425 Formoterol Fumarate and Budesonide Powder for Inhalation IP Budamate 200 Transcaps Lupin Limited India CIC Holdings PLC Accepted
SILMD/2021/02426 Formoterol Fumarate and Budesonide Powder for Inhalation IP Budamate 400 Transcaps Lupin Limited India CIC Holdings PLC Accepted
SILMD/2021/02427 Salmeterol and Fluticasone Propionate Powder for Inhalation IP Esiflo 250 Transcaps Lupin Limited India CIC Holdings PLC Accepted
SILMD/2021/02428 Salmeterol and Fluticasone Propionate Powder for Inhalation I.P. Esiflo 500 Transcaps  Lupin Limited India CIC Holdings PLC Accepted
SILMD/2021/02429 Rosuvastatin Tablet  20 mg Roseday 20 USV Private Limited India Hemas Pharmaceuticals Pvt Ltd Accepted-Existing Product
SILMD/2021/02430 Sodium Chloride Solution BP 0.9% Nasal Spray NASWASH MBL Pharma Pakistan Markss HLC (Pvt) Ltd Accepted
SILMD/2021/02431 Adapalene 0.1% &Benzoyl Peroxide 2.5% Gel (Acneflam Gel) Acneflam Gel Micro Labs Limited India Micro Healthcare (Pvt) Ltd  Accepted
SILMD/2021/02432 Tamsulosin Hydrochloride Prolonged Release Tablets BP 0.2 mg  TASUMAX 0.2 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02433 Danazol Capsules USP 50 mg DANZO 50 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02434 Tamsulosin Hydrochloride Prolonged Release Tablets BP 0.4 mg TASUMAX 0.4 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02435 Abcazole Cream  Abcazole Cream  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02436 Germidine Surgical Scrub  Germidine Surgical Scrub  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02437 Metzen Gel  Metzen Gel  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02438 Silver Z Cream  Silver Z Cream  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02439 Zencaine Gel  Zencaine Gel  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02440 Germidine Antiseptic Gargle  Germidine Antiseptic Gargle  Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02441 Germidine Gargle 2% w/v Germidine Gargle 2% w/v Nanz Med Science Pharma Pvt Ltd  India SMM Halcyon (Pvt) Ltd. Accepted
SILMD/2021/02442 Lidocaine 2 %  + Adrenaline 1 : 80,000  Injection BP Lignox 2% Indoco Remedies Limited India Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02443 Metformin Hydrochloride Sustained Release Tablets USP 500mg (DAOPHAGE SR 500) DAOPHAGE SR 500 Innova Captab India Slim Pharmaceuticals Pvt ltd Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02444 Mematine Hydrochloride Tablets 5mg Admenta 5 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02445 Memantine Hydrochloride Tablets 10mg  Admenta 10 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02446 Oxcarbazepine Tablets USP 300mg  Oxetol 300 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02447 Oxcarbazepine Tablets USP 300mg  Oxetol 300 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02448 Sodium valporate and Valoporic acid Controlled Release Tablets 300mg Encorate Chrono 300 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02449 Cetrizine Hydrochloride Tablets USP 10mg  Cetrizet  Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted-Existing Product
SILMD/2021/02450 Sitagliptin Tablets USP 25mg  ZINCRETIN 25 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02451 Sitagliptin Tablets USP 50mg  ZINCRETIN 50 Cadila Healthcare Limited India Zydus Lanka Private Limited Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02452 Divalporex sodium extended release tablets USP 250mg  Dicorate ER 250 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02453 Zolpidem Tartarate Tablets 10mg  Nitrest 10 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02454 Sodium Valproate and Valproic acid Controlled Release Tablets 200mg  Encorate Chrono 200 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02455 Sodium valproate and Valproic acid Controlled Release Tablets 500mg  Encorate Chrono 500 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02456 Sodium Valproate and Valproic acid Controlled Release Tablets 300mg  Encorate Chrono 300 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02457 Amisulpride Tablets 300mg  Sulpitac 100 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02458 Losartan Potassium Tablets USP 50 mg  EMTAN - 50 MMC Healthcare Ltd India Markss HLC (Pvt) Ltd Accepted
SILMD/2021/02459 Glycopyrrolate Injection USP 200 mcg/ml LICOLATE Samarth Life Sciences Pvt Ltd India Pharma Associates Accepted
SILMD/2021/02460 Methylprednisolone Sodium Succinate for Injection USP 40 mg MYPRED-40 Samarth Life Sciences Pvt Ltd India Pharma Associates Accepted
SILMD/2021/02461 Imiquimod Cream  5%  w/w Aldara Ensign Laboratories Pty. Ltd. Austraila A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02462 Cholecalciferol Tablets BP 1000 IU DVIT 1000 The ACME Laboratories Ltd. Bangladesh Mega Pharma (Pvt) Ltd. Accepted
SILMD/2021/02463 CholecalcIferol Orally Disintegrating Tablets 2000 IU DVIT 2000 The ACME Laboratories Ltd. Bangladesh Mega Pharma (Pvt) Ltd. Accepted
SILMD/2021/02464 Linezolid injection 600mg/300ml LINZO-R R.K. Laboratories (P) Ltd India P.T.C MEDICAL (PVT) LTD Accepted
SILMD/2021/02465 Linagliptin Tablet  5mg  LINESTA 5 Hetero Labs Limited, Unit V India Mansel (Ceylon) (Private) Limited Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02466 Clopidogrel Tablet USP 75 mg   Clopilet 75 Tablets Sun Pharma Laboratories Limited,  India Hemas Pharmaceuticals Pvt Ltd Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02467 Pantoprazole delayed release Tablet, USP 40 mg  Pantocid  Sun Pharmaceutical Industries Limited India Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02468 Pantoprazole delayed release Tablet, USP 20 mg  Pantocid  Sun Pharmaceutical Industries Limited India Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02469 Vitamin D Tablets 1000IU (Dferol)  Dferol  McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02470 Vitamin D Tablet 2000IU (Dferol)  Dferol  McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02471 Vitamin D Tablet 5000IU (Dferol)  Dferol  McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02472 Vitamin D Tablet 60000IU (Dferol)  Dferol  McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02473 Tacrolimus 0.1% w/w  Ointment (DULIMUS FORTE) DULIMUS FORTE DUPEN LABORATORIES PVT. LTD India Bio Tech Pharma (Pvt) Ltd Accepted
SILMD/2021/02474 Hydroquinone IP 2% w/w, Tretinoin USP 0.025% w/w, Mometasone Furoate USP 0.1% w/w , Cream Base Qs  (Piglow Cream) Piglow Cream DUPEN LABORATORIES PVT. LTD India Bio Tech Pharma (Pvt) Ltd Accepted
SILMD/2021/02475 Rosuvastatin Tablets 5mg  ROSTAR 5 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02476 Rosuvastatin Tablets 10mg  ROSTAR 10 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02477 Rosuvastatin Tablets 20mg  ROSTAR 20 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02478 Rosuvastatin Tablets 40mg  ROSTAR 40 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02479 Vitamin C (Ascorbic acid) Chewable Tablets 100mg  Mac-CE McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02480 Vitamin C (Ascorbic acid) Chewable Tablets 500mg (Mac- CE) Mac- CE McW Healthcare (P) Ltd India Innogen Lanka Private Limited Accepted
SILMD/2021/02481 Piperacillin 4g  + Tazobactam 0.5g  Injection (powder for solution for infusion) PIPERTAZ Sandoz GmbH Austria A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02482 Dexamethasone Tablets USP 4 mg DESOLON 4 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02483 Dexamethasone Tablets USP 8 mg DESOLON 8 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02484 Prednisolone Tablet BP 20 mg PESOLON-20 Maxtar Bio-genics India Pharma Associates Accepted
SILMD/2021/02485 Isosobide Mononitrate Extended Release Tablets BP 60MG Monit M/S Stallion Laboratories Private Limited. India SIBA HOLDINGS PVT LTD Accepted
SILMD/2021/02486 Isosobide Mononitrate Extended Release Tablets BP 60mg Monit Ordain Healthcare Global Private Limited India SIBA HOLDINGS PVT LTD Accepted
SILMD/2021/02487 Calcium Carbonate Tablets USP 1.25MG Osthex Ordain Healthcare Global Private Limited India SIBA HOLDINGS PVT LTD Accepted
SILMD/2021/02488 Lamotrigine Dispersible Tablets 25mg   Lamosyn OD 25 Sun Pharmaceuticals Industries Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02489 Lamotrigine Dispersible Tablets 50mg  Lamosyn OD 50 Sun Pharmaceuticals Industries Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02490 Lamotrigine Dispersible Tablets 100mg  Lamosyn OD 100 Sun Pharmaceuticals Industries Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02491 Topiramate Tablets 100mg  Topirol 100 Sun Pharmaceuticals Industries Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02492 Escitalopram Tablets USP 20mg  Nexito 20 Sun Pharmaceutical Industries Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02493 Cefuroxime for Injection USP 250mg  SHAMCEF 250 Shamshree Lifesciences Ltd India Omacx Healthcare Pvt Ltd Accepted
SILMD/2021/02494 Amikacin sulphate injection USP 500mg /2ml   SCOTT-EDIL PHARMACIA LTD India P.T.C MEDICAL (PVT) LTD Sample to be test at NMQAL
SILMD/2021/02495 Clarithromycin Oral suspension USP 125mg/5ml Clarie DS 125 Ind Swift Limited India Alaris Lanka (Private) Limited Rejected under  “need” clause of the
NMRA Act 
SILMD/2021/02496 Ivabradine Tablet 5mg Ivadin -5 Ind Swift Limited India Alaris Lanka (Private) Limited Accepted

Reference No Generic Name Brand Name Manufacturer Name Country Local Agent  MEC Decision
SILMD/2021/02250 Tranexamic Acid Capsules 500mg   Dagon Pharmaceuticals (Pvt) Ltd India Eurochem Biotech  Private Limited  Accepted 
SILMD/2021/02251 Bortezomib for Injection 2 mg BORTETHER 2 Therdose Pharma Pvt. Ltd, India RN Vision Pharma (Pvt) Ltd. Accepted 
SILMD/2021/02252 Ibandronic acid Tablet 150mg    Mylan Laboratories Limited India A. Baur and Co. (Pvt.) Ltd. Accepted 
SILMD/2021/02253 Halobetasol Propionate Ointment 0.05% w/w Halovate Ointment  Glenmark Pharmaceuticals Limited India Sunshine Healthcare Lanka Limited  Accepted 
SILMD/2021/02254 Daclatasvir Tablets 30mg DACIHEP 30 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted 
SILMD/2021/02255 Etoricoxib Tablet (film coated)  120mg  ETORIX 120 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02256 Etoricoxib Tablet (film coated) 60mg  ETORIX 60 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02257 Etoricoxib Tablet (film coated)  90mg  ETORIX 90 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02258 Magaldrate 480mg  + Simeticone 20mg  Chewable Tablets  USP  GASTID  ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Accepted 
SILMD/2021/02259 Bisoprolol Tablet (film coated) USP 2.5mg CARDOBIS 2.5 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Accepted 
SILMD/2021/02260 Bisoprolol Tablet (film coated) USP 5mg  CARDOBIS 5 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02261 Metoprolol Succinate Extended Release Tablets USP 50 mg. Ezapress SR 50 Inventia Healthcare Ltd India Emerchemie NB (Ceylon) Ltd Accepted 
SILMD/2021/02262 Magaldrate 480mg/5ML  + Simeticone 20mg/5ml  Suspension   GASTID  ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Accepted 
SILMD/2021/02263 Metoprolol Succinate Extended Release Tablets USP 25 mg  Ezapress SR 25 Inventia Healthcare Ltd India Emerchemie NB (Ceylon) Ltd Accepted 
SILMD/2021/02264 Salbutamol Sulfate inhalation 100mcg/Puff SALOMAX  Julphar Bangladesh Ltd. Bangladesh TRUVIC PRIVATE LIMITED Accepted 
SILMD/2021/02265 Sitagliptin Tablet USP 50mg  SITAZID 50  ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02266 Sitagliptin Tablet USP 100mg  SITAZID 100 ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02267 Melphalan for Injection 50mg  Lyophilized Powder Eriolan Gland Pharma Limited India Yaden International Private Limited Accepted 
SILMD/2021/02268 Sildenafil Citrate Tablets 50mg  Erix 50mg Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02269 Snake Venom Antiserum Injection (powder, lyophilized, for solution) IP .   Premium Serums & Vaccines Private Limited India George Steuart Health (Pvt.) Ltd Accepted
SILMD/2021/02270 Clopidogrel Tablets USP 75mg  N/A J.Duncan Healthcare Pvt. Ltd India Slim Pharmaceuticals Pvt ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02271 Duloxetine Capsule, delayed release USP 20 mg. DUZELA 20 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02272 Duloxetine Capsule, delayed release USP 30mg DUZELA 30 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02273 Duloxetine Capsule, delayed release USP 60mg  DUZELA 60 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02274   GABASUN 300 Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02275 Imipenem & Cilastatin for Injection USP 500mg IMINEM United Biotech Private Limited India Klintas Pvt Ltd Accepted
SILMD/2021/02276 Salbutamol sulfate inhalation 100 mcg / Puff SALOMAX  ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Accepted
SILMD/2021/02277 Polyethylene Glycol 0.4% w/v  + Propylene glycol 0.3% w/v  Ophthalmic solution   FRESHTEAR ESKAYEF  PHARMACEUTICALS LIMITED  Bangladesh TRUVIC PRIVATE LIMITED Accepted
SILMD/2021/02278 Methylprednisolone Sodium Succinate for Injection USP 500mg SOL-U-PRED 500 United Biotech Private Limited India Klintas Pvt Ltd Accepted
SILMD/2021/02279 Methylprednisolone Sodium Succinate for Injection USP 1g SOL-U-PRED 1000 United Biotech Private Limited India Klintas Pvt Ltd Accepted
SILMD/2021/02280 Meropenem Injection USP 1g  Specbac Injection 1g Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Inform D/NMQAL to submit report regarding all reported qauality failuires of Merapenam Injection. wait until the report
SILMD/2021/02281 Meropenem Injection USP 500mg  Specbac Injection 500mg Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted
SILMD/2021/02282 Zinc sulphate dispersible Tablets 20mg   Square Zinc Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted
SILMD/2021/02283 Etoricoxib Tablets  120mg  Tory 120 Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC If a product is already exist in the market without quality failures inform NMRA to accept sample licence (Policy decision)
SILMD/2021/02284 Etoricoxib Tablets 90mg  Tory 60 Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted-Existing product
SILMD/2021/02285 Etoricoxib Tablets 60mg  Tory 60  Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted-Existing product
SILMD/2021/02286 Etoricoxib Tablets 90mg  Tory 90 Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted-Existing product
SILMD/2021/02287 Azithromycin Tablets USP 500mg   Zimax 500 Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted-Existing product
SILMD/2021/02288 Azithromycin Oral suspension 200mg/5ml Zimax Suspension Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted-Existing product
SILMD/2021/02289 Tranexamic acid Capsules  500mg  Frabex 500 Square Pharmaceuticals Ltd (Dhaka Unit) Bangladesh CIC Holdings PLC Accepted
SILMD/2021/02290 Sorafenib Tosylate Tablets 200mg SORAFENAT Natco Pharma Limited   Sunshine Healthcare Lanka Ltd Accepted
SILMD/2021/02291 Vancomycin Hydrochloride for Injection USP 500mg VANCOTECH 500MG United Biotech Private Limited India Klintas Pvt Ltd Accepted
SILMD/2021/02292 Vancomycin Hydrochloride for Injection USP 1g VANCOTECH 1G United Biotech Private Limited India Klintas Pvt Ltd Accepted
SILMD/2021/02293  (Oseltamivir Phosphate Capsules USP 75mg) Natflu 75 Natco Pharma Limited   Sunshine Healthcare Lanka Ltd Accepted
  44359.64175   36   NATFLU 75 Accepted
SILMD/2021/02294 Typhoid Conjugate Vaccine (Monovalent) [TYPHIBEV]   Biological E.Limited   Sunshine Healthcare Lanka Ltd Accepted
  44359.69502   24   TYPHIBEV Accepted
SILMD/2021/02295 Sterile Water for Injection USP 5mL & 10mL Recowater-5 and Recowater-10 Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02296 Budesonide Nebulizer Suspension BP 0.5mg RESPIBUDE 0.5MG Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02297 Ciprofloxacin Injection USP 2mg/ml KWINCIP Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02298 Dextrose Injection USP 5% W/V Higgsodex-5D Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02299 Fluconazole Injection USP 2mg/ml INFLUCAN Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02300 Lactated Ringer's Injection USP HI RING - RL Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02301 Linezolid Injection 2mg/ml Higgzo Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02302 Metronidazole Injection USP 5mg/mL NIDAGYL Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02303 Levodopa 200mg + Carbidopa 50mg Controlled Release Tablets Syndopa  CR Sun Pharma Laboratories Limited,  India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02304 Sodium Chloride Injection USP 0.9% W/V HI LINE - NS    Higgs Healthcare India Chamee Chemist Accepted
SILMD/2021/02305 Paciltaxel (protein-bound particles) for injection suspension 100mg AB PACLI-100MG BETA DRUGS LIMITED India Adora Ceylon (Pvt) Ltd Accepted
SILMD/2021/02306 Abiraterone acetate 250mg ADBIRON 250MG BETA DRUGS LIMITED India Adora Ceylon (Pvt) Ltd Accepted
SILMD/2021/02307 Gemcitabine injection Lyophilized 200mg AMGICIN 200MG BETA DRUGS LIMITED India Adora Ceylon (Pvt) Ltd Accepted
SILMD/2021/02308 Gemcitabine Injection Lyophilized 1000mg AMGICIN 1000MG BETA DRUGS LIMITED India Adora Ceylon (Pvt) Ltd Accepted
SILMD/2021/02309 Rotavirus Vaccine (Live, Oral) BP 0.5ml/PFS Rotavac 5D Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02310 Rotavirus Vaccine (Live, Oral) BP 0.5ml/Dose Ratavac 5D Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02311 Rotavirus Vaccine (Live, Oral) BP 0.5ml/Dose Ratavac 5D Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02312 Rotavirus Vaccine (Live, Oral) BP 0.5ml/Dose Rotavac 5D Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02313 Typhoid Vi Conjugated Vaccine 0.5ml/Dose Typbar TCV Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02314 Typhoid Vi Conjugated Vaccine 0.5ml/Dose Typbar TCV Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02315 Bivalent Poliomyelitis Vaccine Type 1 & 3 Live Attenuated (Oral) 0.1ml/Dose Biopolio Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02316 Methyl Salicylate 25.5 % w/w, Eucalyptus Oil 10.0% w/w, Menthol 3.3% w/w Cream   Ultimax Cream Hovid Bhd Malaysia Mansel (Ceylon) (Private) Limited Accepted
SILMD/2021/02317 Methylprednisolone Sodium Succinate for IM/IV Injection USP 500mg SOLUPRED IM/IV INJECTION 500mg Ziska Pharmaceuticals Limited  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02318 Cyclosporine Soft Gel Capsules 25mg CYCLORIN 25 Gelnova Laboratories lndia Private Limited India Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02319 Cyclosporine Soft Gel Capsules USP 25mg CYCLORIN 25 Gelnova Laboratories lndia Private Limited India Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02320 Salbutamol 100 mcg  + Beclometasone dipropionate 50 mcg  Pressurised Inhalation   Salbec HFA Inhaler Getz Pharma Pvt Limited Pakistan Hemas Pharmaceuticals Pvt Ltd Accepted
SILMD/2021/02321 Cyclosporine  Soft Gel Capsules USP 50mg CYCLORIN 50 Gelnova Laboratories lndia Private Limited India Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02322 Cyclosporine  Soft Gel Capsules USP 100mg CYCLORIN 100 Gelnova Laboratories lndia Private Limited India Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02323 Afatinib Tablet 20mg AFB 20 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02324 Afatinib Tablet 30mg AFB 30 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02325 Afatinib Tablet 40mg AFB 40 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02326 Brigatinib Tablet 30mg ALUNIB 30 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02327 Brigatinib Tablet 90mg ALUNIB 90 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02328 Brigatinib Tablet 180mg ALUNIB 180 Julphar Bangladesh Ltd. Bangladesh Tabrane Healthcare (Pvt) Ltd Accepted
SILMD/2021/02329 Duloxetine Hydrochloride Capsules USP 20mg  Duzalta 20mg PHARMEVO PVT LTD Pakistan CIC Holdings PLC Accepted
SILMD/2021/02330 Duloxetine Hydrochloride Capsules USP 30mg   Duzalta 30mg PHARMEVO PVT LTD Pakistan CIC Holdings PLC Accepted
SILMD/2021/02331 Duloxetine Hydrochloride Capsules USP 60mg  Duzalta 60mg PHARMEVO PVT LTD Pakistan CIC Holdings PLC Accepted
SILMD/2021/02332 Sitagliptin Tablets USP 25mg ZINCRETIN 25 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02333 Sitagliptin Tablets USP 50mg   Cadila Healthcare Limited   Zydus Lanka Private Limited Accepted
  44362.75035   24   ZINCRETIN 50 Accepted
SILMD/2021/02334 Sitagliptin Tablets USP 100mg ZINCRETIN 100 Cadila Healthcare Limited India Zydus Lanka Private Limited Accepted
SILMD/2021/02335 Sildenafil Citrate Tablets 100mg (SIL 100) SIL 100 DUPEN LABORATORIES PVT. LTD India Bio Tech Pharma (Pvt) Ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02336 Terbutaline Syrup 1.5mg/5ml BUTYLIN SYRUP Hovid Bhd Malaysia Mansel (Ceylon) (Private) Limited Accepted
SILMD/2021/02337 Ibandronic acid Tablet  150mg Bonviva 150mg Penn Pharmaceutical Services Limited United kingdom A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02338 Desloratadine Tablet USP 5mg (Delor) Delor  SEMOS PHARMACEUTICALS  PVT LTD Pakistan Bio Tech Pharma (Pvt) Ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02339 Pertuzumab, Trastuzumab and Hyaluronidase Injection 1200mg,  600mg, 30000 Units in 15ml PHESGO F.Hoffmann-La Roche AG Switzerland A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02340 Prolonged Release Morphine Hydrochloride Trihydrate Tablets 10mg Vendal retard 10mg G.L. Pharma GmbH Austria Yaden International Private Limited Accepted
SILMD/2021/02341 Prolonged Release Morphine Hydrochloride Trihydrate Tablets 30mg Vendal retard 30mg G.L. Pharma GmbH Austria Yaden International Private Limited Accepted
SILMD/2021/02342 Prolonged Release Morphine Hydrochloride Trihydrate Tablets 60mg Vendal retard 60mg G.L. Pharma GmbH Austria Yaden International Private Limited Accepted
SILMD/2021/02343 Leuprolide Acetate Depot Injection 3.75mg   Eriochem S.A.   Yaden International Private Limited Accepted
Lyophilized microspheres for Injection  44363.72411   24   Luprotas Accepted
SILMD/2021/02344 Pertuzumab, Trastuzumab, Hyaluronidase Injection 600mg + 600mg + 20000 Units / 10ml PHESGO F.Hoffmann-La Roche AG Switzerland A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02345 Sodium Valproate And Valproic Acid Controlled Release Tablets 200mg Valsure-200 Swiss Garnier Life Sciences India George Steuart Health (Pvt.) Ltd Accepted
SILMD/2021/02346 Donepezil hydrochloride Tablets USP 5mg  Aldrol 5 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02347 Pantoprazole Sodium Delayed Release Tablet USP 20mg Prantocid Sun Pharmaceutical Industries Limited India Hemas Pharmaceuticals Pvt Ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02348 Sildenafil Citrate Tablets 100mg  Erix 100mg Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02349 Pantoprazole Sodium Delayed Release  Tablet USP 40 mg  Prantocid Sun Pharmaceutical Industries Limited India Hemas Pharmaceuticals Pvt Ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02350 Bromhexine Hydrochloride BP + Phenylephrine Hydrochloride BP + Guaifenesin BP Capsules  Flemnil-RB Capsules Raptakos Brett & Co. Ltd India Pharma Associates Accepted
SILMD/2021/02351 Omeprazole Delayed-Release Capsules USP 20mg Hycid 20 XL Laboratories (Pvt) Ltd  India SMM Halcyon (Pvt) Ltd. Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02352 Pertuzumab, Trastuzumab, Hyaluronidase Injection 1200mg + 600mg  + 30000 Units  / 15ml PHESGO F.Hoffmann-La Roche AG Switzerland A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02353 Donepezil hydrochloride Tablets USP 10mg  Aldrol 10 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02354 Memantine hydrochloride Tablet 10mg  Memtin 10 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02355 Tacrolimus Prolong Release Capsules  0.5 mg  Dailiport Lek Pharmaceuticals d.d. Slovenia A. Baur and Co. (Pvt.) Ltd. Accepted
SILMD/2021/02356 Glibenclamide Tablet BP 5mg   Sunrise International Labs Limited. India Zyrex Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02357 Crizotinib Capsules 250mg  RIZONIB- 250  CAPSULES DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02358 Lenvatinib Capsule 4mg LANIB-4 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02359 Lenvatinib Capsule 10mg  LANIB-10 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02360 Nilotinib Capsule 200 mg  NILONIB-200 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02361 Olaparib Capsules 50 mg  PARIB-50 CAPSULES DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02362 Osimertinib Mesylate Tablet 80 mg  OSINIB-80 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02363 Palbociclib Capsule 125mg  PALBO-125 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02364 Pazopanib Tablet 200mg PAZONIB-200 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02365 Pazopanib Tablet 400mg PAZONIB-400 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02366 Regorafenib Tablet 40mg  RENIB-40 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02367 Ruxolatinib Tablet 5mg RUTINIB-5 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02368 Ruxolatinib Tablet 10 mg  RUTINIB-10 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02369 Ceritinib Capsule 150mg  CERINIB-150 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02370 Japanese Encephalitis Vaccine, Inactivated (Adsorbed, Human) 0.5ml/dose  Jenvac Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02371 Japanese Encephalitis Vaccine, Inactivated (Adsorbed, Human) 0.5ml/dose Jenvac Bharat Biotech International Limited India Gulf Pharma(Pvt)Ltd Accepted
SILMD/2021/02372 Celecoxib Capsule 100mg  Celecoxib Capsules 100mg  Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02373 Celecoxib Capsule  200mg  Celecoxib Capsule  200mg  Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02374 Montelukast Tablets 10mg Zokast 10 Unichem Laboratories Ltd India A. Baur and Co. (Pvt.) Ltd. Accepted-Existing product
SILMD/2021/02375 Diclofenac Potassium Tablet USP 50mg SWISO-P Swiss Pharmaceuticals (Pvt) Ltd, Pakistan Talex Pharma (Pvt) Ltd Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02376 Balanced Salt Solution B-SOL Popular Pharmaceuticals Ltd Bangladesh ABC PHARMA SERVICES (PVT) LTD Accepted
SILMD/2021/02377 Empagliflozin Tablets 10mg Jarzin 10 The Searle Company Limited  Pakistan Morison PLC  Rejected on the
principle of “Need”
clause of the NMRA
act and the
healthcare need of
the country could be
full filled by the
existing products
SILMD/2021/02378 Cyclosporine Capsules USP 50mg Panimun Bioral Panacea Biotec Pharma Limited India Markss HLC (Pvt) Ltd Accepted
SILMD/2021/02379 Cyclosporine Capsules USP 25 mg  Panimun Bioral Panacea Biotec Pharma Limited India Markss HLC (Pvt) Ltd Accepted
SILMD/2021/02380 Vitamin D3 Chewable Tablets CAD D 60000 Finecure Pharmaceuticals Ltd India Biolife Pharmaceuticals (Pvt) Ltd. Accepted
SILMD/2021/02381 Enoxaparin sodium Injection  60mg  LOMOH 60 Gennova Biopharmaceuticals Limited India Emerchemie NB (Ceylon) Ltd Accepted
SILMD/2021/02382 Ibrutinib Capsule 140mg  BUTINIB-140 CAPSULE DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02383 Ceritinib Capsule 450mg  CERINIB-450 CAPSULE  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02384 Filgastrim Injection 300mcg/0.5ml GRAFIL INJECTABLE SOLUTION  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02385 Afatinib Tablet 30mg  ANIB-30 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02386 Afatinib Tablet 40mg  ANIB-40 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02387 Afatinib Tablet 50mg  ANIB-50 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02388 Sunitinib Capsules 12.5mg  SUTINIB- 12.5 CAPSULES DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02389 Sunitinib Capsule 25 mg  SUTINIB-25 DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02390 Sunitinib Capsule 50mg  SUTINIB-50 CAPSULE  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02391 Nilotinib Capsules 150mg  NILONIB-150 CAPSULES DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02392 Ruxolatinib Tablet 15mg  RUTINIB-15 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02393 Ruxolatinib Tablet 20mg  RUTINIB-20 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02394 Lapatinib Tablet 250 mg  LATINIB-250 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02395 Sorafenib Tablet 200mg  SONIB- 200 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02396 Dasatinib Tablet 100mg  DASINIB-100 TABLET  DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02397 Megestrol Tablet 40mg  APIT-40 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02398 Megestrol Tablet 160mg  APIT-160 TABLET DRUG INTERNATIONAL LTD UNIT-2  Bangladesh Tabrane Pharmaceuticals (Pvt) Ltd Accepted
SILMD/2021/02399 Solution for Peritoneal Dialysis Glucose 1.5%, Calcium 1.75mmol/L stay.safe link CAPD/DPCA 2 Fresenius Medical Care Production Sdn. BHD Malaysia Fresenius Medical Care Lanka ( Pvt) Ltd Accepted
SILMD/2021/02400 Solution for Peritoneal Dialysis Glucose 4.25%, Calcium 1.75mmol/L stay.safe link CAPD/DPCA 3 Fresenius Medical Care Production Sdn. BHD Malaysia Fresenius Medical Care Lanka ( Pvt) Ltd Accepted
SILMD/2021/02401 Solution for Peritoneal Dialysis Glucose 2.3%, Calcium 1.75mmol/L stay.safe link CAPD/DPCA 4 Fresenius Medical Care Production Sdn. BHD Malaysia Fresenius Medical Care Lanka ( Pvt) Ltd Accepted
SILMD/2021/02402 Solution for Peritoneal Dialysis Glucose 4.25%, Calcium 1.25mmol/L stay.safe link CAPD/DPCA 18 Fresenius Medical Care Production Sdn. BHD Malaysia Fresenius Medical Care Lanka ( Pvt) Ltd Accepted
SILMD/2021/02403 Solution for Peritoneal Dialysis Glucose 2.3%, Calcium 1.25mmol/L stay.safe link CAPD/DPCA 19 Fresenius Medical Care Production Sdn. BHD Malaysia Fresenius Medical Care Lanka ( Pvt) Ltd Accepted
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Last Update:
15 May 2024.