gov lk

Reg. No.Date of Reg.Generic NameBrand NameDosageManufactureAgentTypeSchedule:Dossier No.
M008930

11-Jan-21

DICLOFENAC POTASSIUM TABLETS USP 50MG

KLODIC

TABLETS

Nabiqasim Industries (Pvt) Ltd, Pakistan

George Steuart Health (Pvt) Ltd

Full

II B

R3475M

M008921

18-Jan-21

ZINC & VITAMIN B COMPLEX FILM COATED TABLETS

XINC B

TABLETS

Eskayef Pharmaceuticals Ltd, Bngladesh

Truvic Private Ltd

Full

II B R2797M

M008901

25-Jan-21

SILDOSIN CAPSULES 4MG

SILOCIN 4

CAPSULES

Bafna Pharmaceuticals Ltd, India

Pharma Associates (Pvt) Ltd

Full

II B NP1403M

Approved list of Medicine from 28th November,2020 to 02nd, January 2021

M008873

28-Nov-20

BETAMETHASONE CREAM USP  0.1% W/W

AXCEL

CREAM

Kotra pharma (M) Ltd, Malaysia

Akbar Pharmaceuticals (Pvt) Ltd

Full

II B

R2835M

M008902

01-Dec-20

DILTIAZEM HYDROCHLORIDE SUSTAINED RELEASE TABLETS 90mg

DILZEM SR

TABLETS

Torrent Pharmaceuticals Ltd, India

Edna Medicals (Pvt) Ltd

Two Years

II B

NP3650M

M008893

03-Dec-20

SITAGLIPTIN TABLETS USP 100MG

SITALO  100

FILM COA TABLETS

Celogen Lanka (Pvt) Ltd, Sri Lanka

Celogen Lanka (Pvt) Ltd

Two Years

II B

NP3863M LMP

M007705

09-Dec-20

NANOCOG GAMMA HUMAN COAGULATION FACTOR IX 500IU (RECOMBINANT)

RIXUBIS

POWDER FOR INJECTION

Baxalta Belgium Manufacturing S A, Belgium

A J Medichem international Ltd

Full

II B

NP3383M

M007320

09-Dec-20

ROSUVASTATIN TABLETS 20MG

ROST 20

TABLETS

Hetero Labs Ltd, India

Mansel (Ceylon) (Pvt) Ltd

Two Years

II B

NP3248M

M007558

17-Dec-20

MIRTAZAPINE TABLET USP 15MG

MIRTAZ 15

TABLETS

Sun Pharma Laboratories Ltd, India

Emerchemie NB (Ceylon) Ltd

Full

II B

R3214M

M008188

20-Dec-20

PAEDIATRIC PARACETAMOL ORAL SOLUTION BP 120MG/5ML

*******

ORAL SOLUTION

Gamma Pharmaceuticals (Pvt) Ltd, Sri Lanka

Gamma Pharmaceuticals (Pvt) Ltd

Two Years

II B

NP3059M

M008846

20-Dec-20

METRONIDAZOLE INJECTION USP 0.5%

METRIS

INJECTION

Otsuka Pharmaceuticals (Pvt) Ltd, India

Akbar Pharmaceuticals (Pvt) Ltd

Full

II B

R1893M

M008684

21-Dec-20

LINAGLIPTIN TABLETS 5MG

TRANETA

TABLETS

Beximco Pharmaceuticals Ltd, Bangladesh

Emerchemie NB (Ceylon) Ltd

Full

II B

R1983M

M008149

23-Dec-20

CARBOCISTEINE ORAL SUSPENSION 500MG/5ML

SOLMUX FORTE

ORAL SUSPENSION

Amherst Laboratories, Philippines

George Steuart Health (Pvt) Ltd

Two Years

II B

NP2760M

M008306

23-Dec-20

BICALUTAMIDE TABLETS 50MG

***

TABLETS

Bafna Pharmaceuticals Ltd

Pharma Associates

Two Years

II B

NP2239M

M008197

23-Dec-20

GLICLAZIDE TABLETS BP 40MG

GLIVIC 40MG

TABLETS

Astron (Pvt) Ltd

Astron (Pvt) Ltd

Two Years

II B

NP1865M

M008289

26-Dec-20

SODIUM VALPROATE TABLETS ENTERIC COATED TABLETS TABLETS BP 200mg

ENCORATE

TABLETS

Sun Pharmaceutical industries

Emerchemie NB (Ceylon) Ltd

Full

II B

R2326M

M008295

26-Dec-20

HEPARIN INJECTION BP 25,000 IU/5ML

RINHEPA 25

SOLUTION FOR INJECTION

United Biotech (Pvt) Ltd

Klintas (Pvt) Ltd

Full

II B

NP1409M

M007367

31-Dec-20

TERBINAFINE HYDROCHLORIDE CREAM 1% W/W

TERBISIL CREAM

CREAM

Saffron Pharmaceutical (Pvt) Ltd

Truvic Private Ltd

Two Years

II B

NP2783M

M008854

31-Dec-20

TAMSULOSIN HYDROCHLORIDE MODIFILED RELEASE CAP 400MCG

URIMAX 0.4 mg

MODIFIED RELEASE TABLETS

Cipla Ltd

Breathe Free Lanka (Pvt) Ltd

Full

II B

R2406M

M008315

31-Dec-20

AZITHROMYCIN TABLETS USP 500MG

AZA-500

TABLETS

XL Laboratories (Pvt) Ltd

SMM Halcyon (Pvt) Ltd

Two Years

II B

R3104M

M008522

02-Jan-21

GEFITINIB TABLET 250MG

GEFTIWEL 250

TABLETS

Getwell Pharmaceuticals

The Esses Pharmacy (Pvt) Ltd

Full

II B

NP2043M

M008567

02-Jan-21

IMATINIB TABLETS 400MG

MATINIB 400

TABLETS

Getwell Pharmaceuticals

The Esses Pharmacy (Pvt) Ltd

Full

II B

NP2044M

Approved list of Medicine from 28th November,2020 to 02nd, January 2021
M008873

28-Nov-20

BETAMETHASONE CREAM USP  0.1% W/W

AXCEL

CREAM

Kotra pharma (M) Ltd, Malaysia

Akbar Pharmaceuticals (Pvt) Ltd

Full

II B

R2835M

M008902

01-Dec-20

DILTIAZEM HYDROCHLORIDE SUSTAINED RELEASE TABLETS 90mg

DILZEM SR

TABLETS

Torrent Pharmaceuticals Ltd, India

Edna Medicals (Pvt) Ltd

Two Years

II B

NP3650M

M008893

03-Dec-20

SITAGLIPTIN TABLETS USP 100MG

SITALO  100

FILM COA TABLETS

Celogen Lanka (Pvt) Ltd, Sri Lanka

Celogen Lanka (Pvt) Ltd

Two Years

II B

NP3863M LMP

M007705

09-Dec-20

NANOCOG GAMMA HUMAN COAGULATION FACTOR IX 500IU (RECOMBINANT)

RIXUBIS

POWDER FOR INJECTION

Baxalta Belgium Manufacturing S A, Belgium

A J Medichem international Ltd

Full

II B

NP3383M

M007320

09-Dec-20

ROSUVASTATIN TABLETS 20MG

ROST 20

TABLETS

Hetero Labs Ltd, India

Mansel (Ceylon) (Pvt) Ltd

Two Years

II B

NP3248M

M007558

17-Dec-20

MIRTAZAPINE TABLET USP 15MG

MIRTAZ 15

TABLETS

Sun Pharma Laboratories Ltd, India

Emerchemie NB (Ceylon) Ltd

Full

II B

R3214M

M008188

20-Dec-20

PAEDIATRIC PARACETAMOL ORAL SOLUTION BP 120MG/5ML

*******

ORAL SOLUTION

Gamma Pharmaceuticals (Pvt) Ltd, Sri Lanka

Gamma Pharmaceuticals (Pvt) Ltd

Two Years

II B

NP3059M

M008846

20-Dec-20

METRONIDAZOLE INJECTION USP 0.5%

METRIS

INJECTION

Otsuka Pharmaceuticals (Pvt) Ltd, India

Akbar Pharmaceuticals (Pvt) Ltd

Full

II B

R1893M

M008684

21-Dec-20

LINAGLIPTIN TABLETS 5MG

TRANETA

TABLETS

Beximco Pharmaceuticals Ltd, Bangladesh

Emerchemie NB (Ceylon) Ltd

Full

II B

R1983M

M008149

23-Dec-20

CARBOCISTEINE ORAL SUSPENSION 500MG/5ML

SOLMUX FORTE

ORAL SUSPENSION

Amherst Laboratories, Philippines

George Steuart Health (Pvt) Ltd

Two Years

II B

NP2760M

M008306

23-Dec-20

BICALUTAMIDE TABLETS 50MG

***

TABLETS

Bafna Pharmaceuticals Ltd

Pharma Associates

Two Years

II B

NP2239M

M008197

23-Dec-20

GLICLAZIDE TABLETS BP 40MG

GLIVIC 40MG

TABLETS

Astron (Pvt) Ltd

Astron (Pvt) Ltd

Two Years

II B

NP1865M

M008289

26-Dec-20

SODIUM VALPROATE TABLETS ENTERIC COATED TABLETS TABLETS BP 200mg

ENCORATE

TABLETS

Sun Pharmaceutical industries

Emerchemie NB (Ceylon) Ltd

Full

II B

R2326M

M008295

26-Dec-20

HEPARIN INJECTION BP 25,000 IU/5ML

RINHEPA 25

SOLUTION FOR INJECTION

United Biotech (Pvt) Ltd

Klintas (Pvt) Ltd

Full

II B

NP1409M

M007367

31-Dec-20

TERBINAFINE HYDROCHLORIDE CREAM 1% W/W

TERBISIL CREAM

CREAM

Saffron Pharmaceutical (Pvt) Ltd

Truvic Private Ltd

Two Years

II B

NP2783M

M008854

31-Dec-20

TAMSULOSIN HYDROCHLORIDE MODIFILED RELEASE CAP 400MCG

URIMAX 0.4 mg

MODIFIED RELEASE TABLETS

Cipla Ltd

Breathe Free Lanka (Pvt) Ltd

Full

II B

R2406M

M008315

31-Dec-20

AZITHROMYCIN TABLETS USP 500MG

AZA-500

TABLETS

XL Laboratories (Pvt) Ltd

SMM Halcyon (Pvt) Ltd

Two Years

II B

R3104M

M008522

02-Jan-21

GEFITINIB TABLET 250MG

GEFTIWEL 250

TABLETS

Getwell Pharmaceuticals

The Esses Pharmacy (Pvt) Ltd

Full

II B

NP2043M

M008567

02-Jan-21

IMATINIB TABLETS 400MG

MATINIB 400

TABLETS

Getwell Pharmaceuticals

The Esses Pharmacy (Pvt) Ltd

Full

II B

NP2044M

Approved list of Medicine from 21.10.2020 to 09.12.2020
M007466 22-Oct-20 DIPHTHERIA AND TETANUS VACCINE ADSORBED PAEDIATRIC 10 DOSE ***** INJECTION Serum Institute of India (Pvt) Ltd, India Citihealth Imports (Pvt) Ltd PR-2Y II B R3307M
M008797 27-Oct-20 CETIRIZINE ORAL SOLUTION BP 5MG/5ML AXCEL CETIRIZINE ORAL SOLUTION Kotra pharma (M) Ltd, Malaysia Akbar Pharmaceuticals (Pvt) Ltd Full II B 22341
M007395 27-Oct-20 ALENDRONIC ACID TABLETS USP 70MG OSTEOMAX 70 TABLETS Zim Laboratories Ltd, India Tabrane Pharmaceuticals (Pvt) Ltd Full II B R3391M
M008827 31-Oct-20 SODIUM CHLORIDE INJECTION USP 0.9 % *** INJECTION Baxter Healthcare Philippines inc, Philippines CIC Holdings PLC Full II B NP1361M
M008741 01-Nov-20 AMOXICILLIN & CLAVULANATE POTASSIUM TABLETS USP 625MG KLAMOKS BID TABLETS Bilim Ilac Sanayi Ve Ticaret Anonim Sirketi, Turkey Slim Pharmaceuticals (Pvt) Ltd Full II B NP1702M
M008859 17-Nov-20 PANCREATIN CAPSULES 150MG (AMAYLASE-8,000 IU, LIPASE 10,000IU, PROTEASE 600IU) *** CAPSULES Celogen Lanka (Pvt) Ltd, Sri Lanka Celogen Lanka (Pvt) Ltd PR-1Y II B NP3116M LMP
M007396 21-Nov-20 TOLTERODINE EXTENDED RELEASE CAPSULES 2MG TOLADINE CAPSULES Zim Laboratories Ltd, India Tabrane Pharmaceuticals (Pvt) Ltd Full II B R3398M
M008250 26-Nov-20 METARAMINOL INJECTION BP 10MG/1ML METACRAFI INJECTION United Biotech (Pvt) Ltd, India Klintas (Pvt) Ltd Full II B NP1631M
M007840 27-Nov-20 ESOMEPRAZOLE POWDER FOR INJECTION 40MG EMEP POWDER FOR INJECTION Aristopharma Ltd, Bangladesh Hemas Pharmaceuticals (Pvt) Ltd PR-2Y II B NP150M
M008682 06-Dec-20 PREGABALIN SUSTAINED RELEASE TABLETS 150MG SEGABIN SR 150 TABLETS Inventia Healthcare (Pvt) Ltd, India Emerchemie NB (Ceylon) Ltd Full II B 19437
M007705 09-Dec-20 NANOCOG GAMMA HUMAN COAGULATION FACTOR IX 500IU (RECOMBINANT) RIXUBIS POWDER FOR INJECTION Baxalta Belgium Manufacturing S A, Belgium A J Medichem international Ltd Full II B NP3383M
M007320 09-Dec-20 ROSUVASTATIN TABLETS 20MG ROST 20 TABLETS Hetero Labs Ltd, India Mansel (Ceylon) (Pvt) Ltd PR-2Y II B NP3248M
Approved list of Medicine from 01st September to 20th October 2020
M008373 R1404M 01-Sep-20 ETOFYLLINE & THEOPHYLLINE PROLONGED RELEASE TABLETS IP 300MG DERIPHYLLIN OD 300 TABLETS Cadila Healthcare Ltd, India Sunshine Healthcare lanka Ltd Full

 

II B

M007592 NP2381M 10-Sep-20 DOMPERIDONE SUPPOSITORIES 30MG *** SUPPOSITORY Meridian Enterprises Pvt Ltd, India Accorria Pharmaceuticals Full

 

II B

M007658 R3392M 12-Sep-20 CLARITHROMYCIN TABLETS USP 250MG CLARILET 250 TABLETS Zim Laboratories Ltd, India Tabrane Healthcare (Pvt) Ltd Full

 

II B

M007675 R3375M 12-Sep-20 MELOXICAM TABLETS BP 7.5MG LOXICAM TABLETS Zim Laboratories Ltd, India Tabrane Pharmaceuticals (Pvt) Ltd Full

 

II B

M008033 R3107M 13-Sep-20 MONTELUKAST CHEWABLE TABLETS 5MG MONOCAST 5 TABLETS Beximco Pharmaceuticals Ltd,Bangladesh Emerchemie NB (Ceylon) Ltd Full

 

II B

M008585 R3412M 09-Oct-20 TERBINAFINE HYDROCHLORIDE CREAM 1% W/W FINTRIX TOPICAL CREAM Micro Labs Ltd, India Micro Healthcare (Pvt) Ltd Full

 

II B

M008224 NP3286M 10-Oct-20 CIPROFLOXACIN TABLETS USP 250MG CIPRODEX 250 TABLETS CIC Lifesciences Ltd. CIC Lifesciences Ltd. Full

 

II B

M008242 23266 19-Oct-20 ALBUMIN HUMAN SOLUTION FOR INJECTION 20% ALBURX 20% SOLUTION FOR IV INFUSION CSL Behring GmbH, Switzerland ABC Pharma Services Pvt. Ltd PR-2 Y

 

II B

Approved list of Medicine from 01st of August to 31st August 2020
M008550 R2439M 1-Aug-20 ZINC SULPHATE SYRUP 20MG/5ML ZINCO PLUS Syrup MBL Pharma, Pakistan Markss HLC (Pvt) Ltd PR – 2y II B
M008372 NP1553M 2-Aug-20 VANCOMYCIN HYDROCHLORIDE FOR INJECTION USP 1G VANBACT-1G Injection Nabiqasim Industries (Pvt) Ltd, Pakistan George Steuart Health (Pvt) Ltd FR II B
M008605 NP1587M 6-Aug-20 PIRFENIDONE TABLETS 200MG *** Tablets Mercury Laboratories (Pvt) Ltd,India Yaden International (Pvt) Ltd PR – 2y II B
M008298 NP2923M 6-Aug-20 LABETALOL HYDROCHLORIDE TABLETS USP 100MG *** Tablets Centurion Laboratories Pvt Ltd, India Yaden International (Pvt) Ltd FR II B
M008460 NP2124M 7-Aug-20 KETOPROFEN GEL 2.5% W/W KALTROFEN Gel P T Kalbe Farma, Indonesia Hemas Pharmaceuticals FR II B
M008658 NP2160M 9-Aug-20 AMOXICILLIN & CLAVULANATE POTASSIUM ORAL SUSPENSION USP 156.25mg/5ML INDCLAV 156 Powder For Oral Suspension Indchemie Health, India Pharma Associates (Pvt) Ltd PR – 2y II B
M005453 NP2124M 12-Aug-20 AMOXICILLIN & CLAVULANIC ACID DRY POWDER FOR ORAL SUSPENSION USP 156.25mg KOACT 156.25 Powder For Oral Suspension Aurobindo Specialities Pharama (Pvt) Ltd,India Alaris Lanka (Pvt) Ltd FR II B
M007244 NP1643M 14-Aug-20 SODIUM HYALURONATE OPHTHALMIC SOLUTION 1.8% HYVET-ES Solution Sunway Rohto Pharmaceutical, India Yaden International (Pvt) Ltd PR – 2y II B
M008483 NP2797M 17-Aug-20 DOCETAXEL INJECTION USP 20MG/0.5ML DOCET Injection VENUS Remedies,India Ceyoka (Pvt) Ltd FR II B
M08296 NP3064RR 18-Aug-20 PROPOFOL INJECTION 10MG/ML PROPOFOL LIPURO 1% Injection B Braun Melsungen A G, Germany B Braun Lanka (Pvt) Ltd PR – 2y II B
M008526 R10636 19-Aug-20 GEFITINIB TABLET IP 250MG GEFTINAT 250 Tablets Natco Pharma Ltd,India Sunshine Healthcare lanka FR II B
M008364 M3861N LMP 19-Aug-20 FEXOFENADINE HYDROCHLORIDE TABLETS USP 180MG FENADIN 180 Film Coated Tablets Renata Limited, Bangladesh Emerchemie NB (Ceylon) Ltd FR II B
M008215 R2235M 24-Aug-20 BOSENTAN TABLETS 125MG PULMOFIRST 125 Tablets MSN Laboratories Ltd,India Axia (Pvt) Ltd FR II B
M008227 R2234M 24-Aug-20 BOSENTAN TABLETS 62.5MG PULMOFIRST 62.5 Tablets MSN Laboratories Ltd,India Axia (Pvt) Ltd FR II B
M008664 R2192M 27-Aug-20 GLUCOSE INJECTION BP 50% w/v *** Iv Infusion B Braun Medical Industries, Malaysia B Braun Lanka (Pvt) Ltd PR – 2y II B
M008191 MED147NMRA 28-Aug-20 GLICLAZIDE TABLETS BP 40MG ******* Tablets State Pharmaceuticals Manufacturing Coperation, Sri Lanka State Pharmaceuticals Manufacturing Coperation, Sri Lanka FR II B
M008221 24577 31-Aug-20 PREGABALIN CAPSULES 75MG PREGASAFE 75 Capsules MSN Laboratories, India Axia (Pvt) Ltd FR II B
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 info@nmra.gov.lk