| Reference No | Generic Name | BRAND NAME | Manufacturer Name | Country | Local Agent | MEC decision |
| MEDREG/2020/00452 | Ciclosporin Capsule, soft gelatin USP 50mg | PICOSPORIN 50 | United Biotech Private Limited | India | Klintas Pvt Ltd | Accepted |
| MEDREG/2021/00870 | Itraconazole Capsules 100mg | IZOLE | Navana Pharaceuticals Ltd | Bangladesh | Darley Butler And Co 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 | ||||||
| MEDREG/2021/00923 | Bisoprolol Tablet USP 5 | BISOPRESS 5 TABLET | Nipro Jmi Pharma Ltd. | Bangladesh | Imedra Healthcare (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 | ||||||
| MEDREG/2021/01053 | Ipratropium bromide500 mcgSalbutamol2.5 mg in 2.5 ml Respiratory solution | DUOLIN RESPULES | Cipla Ltd | India | Breathe Free Lanka (Private) Limited | Accepted |
| MEDREG/2021/01060 | Fludrocortisone acetate Tablet (uncoated) IP 100 mcg | FLORICOT | Samarth Life Sciences Pvt Ltd | India | Pharma Associates | Accepted |
| MEDREG/2021/01094 | Lenalidomide Capsule 15mg | LINADEX 15 | Hetero Labs Limited, Unit V | India | Mansel (Ceylon) (Private) Limited | Accepted |
| MEDREG/2021/01098 | Dextromethorphan10mg Phenylephrine hydrochloride5mgChlorpheniramine2mg Syrup | ASCODEX SYRUP | Glenmark Pharmaceuticals Limited - Unit Ii | India | Sunshine Healthcare Lanka Limited | Accepted |
| MEDREG/2021/01106 | Milrinone Injection (solution) 10mg/10ml | MILICOR | Samarth Life Sciences Pvt Ltd | India | Pharma Associates | Accepted |
| MEDREG/2021/01132 | Levothyroxine sodium Tablet 137mcg | T4 MONTPELLIER 137 | Quimica Montpellier S.A. | Argentina | Emerchemie Nb (Ceylon) Ltd | Accepted |
| MEDREG/2021/01139 | Gemcitabine Injectables 1g/26.3mL | Shilpa Medicare Limited | India | Slim Pharmaceuticals Pvt Ltd | Accepted | |
| MEDREG/2021/01141 | Methylene Blue Injection (solution) USP 10mg/mL | BLUE BEAM | Divine Laboratories Pvt. Ltd | India | Slim Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01144 | Flunarizine Tablet 10mg | NORIUM 10 | Eskayef Pharmaceuticals Limited | Bangladesh | Truvic Private Limited | Accepted |
| MEDREG/2021/01187 | Levetiracetam Tablet (film coated) USP 500mg | JULITAM 500 | Cadila Healthcare Limited | India | Zydus Lanka Private Limited | Accepted |
| MEDREG/2021/01194 | Duloxetine Capsule, delayed release USP 30mg | DULEVE 30 | Cadila Healthcare Limited | India | Zydus Lanka Private Limited | Accepted |
| MEDREG/2021/01198 | Estradiol Valerate Tablet 1 mg | PROGYNOVA 1 MG | Bayer Weimar Gmbh Und Co. KG | Germany | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01199 | Cefepime Injection (powder for solution) USP 1g | PIME S | Sanjivani Parenteral Limited | India | Canoe Medicare (Pvt) Ltd | Accepted |
| MEDREG/2021/01203 | Minoxidil Topical Solution BP 5% w/v | Eskayef Pharmaceuticals Limited | Bangladesh | Truvic Private Limited | Accepted | |
| MEDREG/2021/01204 | Flunarizine Tablet 5mg | MGR 5 | Inga Laboratories Private Limited | India | George Steuart Health (Pvt.) Ltd | Accepted |
| MEDREG/2021/01206 | Lamotrigine Tablet, dispersible 50mg | EPSYLAM DT 50 | Aurobindo Pharma Limited | India | Alaris Lanka (Private) Limited | Accepted |
| MEDREG/2021/01209 | Cefixime Capsule 200mg | KEFIXIM 200 | Eskayef Pharmaceuticals Limited | Bangladesh | Truvic Private Limited | Accepted |
| MEDREG/2021/01215 | Fusidic acid Cream BP 2% w/w | FACIDO C | 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 | ||||||
| MEDREG/2021/01216 | Methotrexate Injection (solution) USP 500mg/5ml | METHOCEL 500 | Celon Laboratories Private Limited | India | Medmart Pharma (Pvt) Ltd | Accepted |
| MEDREG/2021/01219 | Doxorubicin hydrochloride Injection (solution) USP 10 mg per 5ml | ROBOL ( 10 MG PER 5ML) | Venus Remedies Limited | India | Yaden International Private Limited | Accepted |
| MEDREG/2021/01222 | Ezetimibe Tablet 10mg | EZIT | Hetero Labs Limited, Unit Iii | India | Mansel (Ceylon) (Private) Limited | Accepted |
| MEDREG/2021/01229 | Doxorubicin hydrochloride Injection (liposomal) 20mg/10ml | LIPPOD 20 | Celon Laboratories Private Limited | India | Medmart Pharma (Pvt) Ltd | Accepted |
| MEDREG/2021/01236 | Doxorubicin hydrochloride Injection (liposomal) 50mg/25ml | LIPPOD 50 | Celon Laboratories Private Limited | India | Medmart Pharma (Pvt) Ltd | Accepted |
| MEDREG/2021/01251 | Methylprednisolone Tablet (uncoated) BP 4mg | MYSOLONE 4 | Zee Laboratories | India | Abc Pharma Services (Pvt) Ltd | Accepted |
| MEDREG/2021/01266 | Dorzolamide2% w/vTimolol0.5% w/v Ophthalmic solution USP | TILOMIDE | Shaigan Pharmaceuticals (Pvt) Ltd. | Pakistan | Abc Pharma Services (Pvt) Ltd | Accepted |
| MEDREG/2021/01296 | Rifaximin Tablet (film coated) 550 mg | Mercury Laboratories Limited | India | Yaden International Private Limited | Accepted | |
| MEDREG/2020/00183 | Cefixime Tablet, dispersible 200mg | CIFATAZE DT 200 | Sterling Lab | India | Darley Butler And Co Ltd | Accepted –Existing product Request BE/BW and Sales details (State sector and Private sector) |
| MEDREG/2020/00463 | Glimepiride Tablet (uncoated) 4mg | EUGLIM 4 | Cadila Healthcare Limited | India | Sunshine Healthcare Lanka Limited | Accepted |
| MEDREG/2021/00731 | Flucloxacillin Capsules BP 250mg | FLUSTAPH 250 | Orion Pharma Ltd. | Bangladesh | Darley Butler And Co Ltd | Accepted |
| MEDREG/2021/00784 | Polysaccharide iron complex Syrup 50mg/5mL | APOFER SYRUP | Platinum Pharmaceuticals Private Limited | Pakistan | George Steuart Health (Pvt.) Ltd | Accepted |
| MEDREG/2021/00860 | Pregabalin Capsules 150mg | NOVAPREG 150 | Innova Captab | India | Slim Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/00895 | Montelukast Tablet 10 mg | MONTAIR 10 | Cipla Limited | India | Breathe Free Lanka (Private) Limited | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/00902 | Chloramphenicol Eye and Ear drops USP 0.5 % W/V | CLOZE | Megasys Biotek Pvt.Ltd | India | Pharmatec Pvt Ltd | Accepted |
| MEDREG/2021/00918 | Selenium0.02mgVitamin A5000IUVitamin C (Ascorbic acid)500mgVitamin E (Tocopherol)100mg Tablet (film coated) | ZEEST | Tabros Pharma Pvt Ltd, | Pakistan | Associated Laboratories (Private) Limited | to Borderline classification |
| MEDREG/2021/00924 | Metformin Tablet (film coated) BP 500 mg | GLYCOMET 500 | Fredun Pharmaceuticals Limited | India | Hemas Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01079 | Alfacalcidol Capsule 1.0 mcg | ALPHADOL 1 | Panacea Biotec Pharma Limited | India | Markss Hlc (Pvt) Ltd | Accepted |
| MEDREG/2021/01081 | Atorvastatin Tablet 10mg | ATORNOVA 10 | Innova Captab | India | Slim Pharmaceuticals Pvt Ltd | Accepted -Existing product |
| .Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01099 | Itraconazole Capsules 100 mg | SPORANOX | Janssen Cilag Spa | Italy | Pettah Pharmacy (Private) Limited | Accepted -Existing product |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01116 | Betamethasone Dipropionate Cream USP 0.064% w/w | BEPROSONE CREAM | Hoe Pharmaceuticals Sdn. Bhd. | Malaysia | Indoscan (Pvt) Ltd | Accepted |
| MEDREG/2021/01171 | Fusidic acid2.0% w/wHydrocortisone1.0% w/w Cream | DISUF – H CREAM | Hovid Bhd | Malaysia | Mansel (Ceylon) (Private) Limited | Accepted -Existing product |
| .Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01173 | Chloramphenicol Ophthalmic ointment USP 1% | OCUMYCIN | Centaur Pharmaceuticals Private Limited | India | George Steuart Health (Pvt.) Ltd | Accepted |
| MEDREG/2021/01184 | Cefuroxime axetil Tablet USP 250mg | PULMOCEF 250 | Micro Labs Ltd | India | Micro Healthcare (Pvt) Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01186 | Amoxicillin Oral Suspension USP 125mg/5ml | UMOXIL 125 DS | Uni Medicolabs | India | Slim Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01192 | Ketoconazole Shampoo 2% w/w | KETOVID SHAMPOO 2% | Hovid Bhd | Malaysia | Mansel (Ceylon) (Private) Limited | Accepted |
| MEDREG/2021/01227 | Glucose Intravenous Infusion BP 50 g/L [ 5 % ] | GLUCOSE 5% | Fresenius Kabi India Private Limited | India | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01231 | Lidocaine60 mgHydrocortisone5 mg Suppository | XYLOPROCT | Recipharm Karlskoga Ab | Sweden | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01242 | Itraconazole Capsules 100mg | CITROZ CAP | Cian Healthcare Pvt. Ltd, | India | Slim Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01245 | Povidone-iodine Ointment USP 5.0% W/W | IODIN PLUS OINTMENT | Cian Healthcare Pvt. Ltd, | India | Slim Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01257 | Fusidic acid Cream BP 20 mg/g | FUSIBACT | Cipla Limited | India | Breathe Free Lanka (Private) Limited | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01259 | Lidocaine50 mg/ gHydrocortisone2.5 mg/ g Ointment | XYLOPROCT | Recipharm Karlskoga Ab | Sweden | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01270 | Cefuroxime Injection (powder for solution) USP 750mg | SHAMCEF 750 | Shamshree Lifesciences Ltd | India | Omacx Healthcare Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01272 | Glimepiride Tablet (uncoated) USP 1 mg | GP 1 | Fredun Pharmaceuticals Limited | India | Hemas Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01273 | Folic acid Tablet BP 1mg | INGAFOL 1 | Inga Laboratories Private Limited | India | George Steuart Health (Pvt.) Ltd | Accepted |
| MEDREG/2020/00196 | Cefalexin Capsule BP 250mg | CEPHAST 250 | Sterling Lab 57 | India | Darley Butler And Co Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2020/00255 | Vitamin B Complex Tablet (uncoated) Niacinamide10mgThiamineMononitrate1mgRiboflavin1mg | Bafna Pharmaceuticals Ltd | India | Pharma Associates | Accepted | |
| MEDREG/2020/00293 | Lidocaine hydrochloride Jelly 2% | XYLOCAINE JELLY | Recipharm Karlskoga Ab | Sweden | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2020/00331 | Isosorbide mononitrate Tablet, extended release USP 30mg | SOLOTRATE SR 30 | Cadila Healthcare Limited | India | Sunshine Healthcare Lanka Limited | Accepted |
| MEDREG/2020/00347 | Sodium valproate Gastro-Resistant Tablets BP 200 mg | S VALAPRO 200 | Amn Life Science Pvt Ltd | India | Pharma Associates | Accepted |
| MEDREG/2020/00396 | Clotrimazole Cream USP 1% w/w | CANDID CREAM | Glenmark Pharmaceuticals Limited | India | Sunshine Healthcare Lanka Limited | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/00805 | Tenofovir Disoproxil Tablet 300 mg | TENVIR | Cipla Limited | India | Breathe Free Lanka (Private) Limited | Accepted |
| MEDREG/2021/00953 | Cefixime Tablet USP 200mg | CHIFIX 200 | Chirospharma | India | Slim Pharmaceuticals Pvt Ltd | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01114 | Metformin Tablet (film coated) USP 850mg | BIGSENS 850 | Cadila Healthcare Limited | India | Sunshine Healthcare Lanka Limited | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01165 | Pantoprazole Injection (powder, lyophilized, for solution) 40 mg/vial | PANTOCID I.V. | Sun Pharmaceutical Industries Limited | India | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01179 | Alendronate sodium Tablet USP 70 mg | REVENTA | Getz Pharma (Pvt) Ltd | Pakistan | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| MEDREG/2021/01225 | Montelukast Tablet, chewable USP 5 mg | AIREEZ 5 | Pharmevo Pvt Ltd | Pakistan | Cic Holdings Plc | Accepted -Existing product. |
| Request BE/BW and Sales details (State sector and Private sector) | ||||||
| MEDREG/2021/01237 | Povidone-iodine Gel 0.5 % w/w ( 5.0 g/100 g ) | PYODINE GEL | Brookes Pharma (Pvt) Ltd | Pakistan | Hemas Pharmaceuticals Pvt Ltd | Accepted |
| Reference No | Name of the Product | Brand Name | Manufacturer | Importer | MEC decision |
|---|---|---|---|---|---|
| MEDREG/2020/00062 | Betahistine Tablet BP 8 mg | DIZIMA RC 8mg | Healer's Lab, Unit II | Canoe Medicare (Pvt) Ltd | Rejected informing that the healthcare need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00104 | Povidone-iodine Aerosol, spray USP 5.00 % w/w | VINODINE | Midas Care Pharmaceuticals Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2020/00372 | Ondansetron Tablet 4mg | Aurodanz 4 | Aurobindo Pharma Limited | Alaris Lanka (Private) Limited | Accepted for review |
| MEDREG/2020/00395 | Telmisartan Tablet USP 80mg | T SAR | CCL Pharmaceuticals Pvt Ltd | CIC Holdings PLC | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00526 | Terbinafine Tablet BP 250mg | FUNGIFEX 250 | Remedica Limited | Kandana Food And Drugs (PVT) LTD. | Accepted for review |
| MEDREG/2020/00536 | Losartan potassium50 mg Hydrochlorothiazide12.5 mg Tablet (film coated) | Zaart H | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review |
| MEDREG/2020/00549 | Hyoscine butylbromide Injection (solution) BP 20 mg / ml | Ciron Drugs and Pharmaceuticals Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2020/00551 | Phenobarbitone Injection (solution) BP 200 mg / ml | Ciron Drugs and Pharmaceuticals Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2020/00554 | Methylprednisolone Tablet IP 4 mg | M NISOL 4 | Steril gene Life Sciences P Ltd | Pharma Associates | Accepted for review |
| MEDREG/2020/00571 | Pregabalin Capsules 75mg | PEGALIN 75 | Shaigan Pharmaceuticals (Pvt) Ltd. | ABC PHARMA SERVICES (PVT) LTD | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00577 | Erlotinib Tablet 100mg | Shilpa Medicare Limited | Slim Pharmaceuticals Pvt ltd | Accepted for review | |
| MEDREG/2020/00583 | Gadoteric acid Injection (solution) 0.5mmol/ml | CLARISCAN | GE Healthcare AS | Sunshine Healthcare Lanka Ltd | Accepted for review |
| MEDREG/2021/00598 | Azithromycin Tablet USP 500 mg | AZINAM 500 | AMN Life Science Pvt Ltd | Pharma Associates | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00619 | Levofloxacin Tablet (film coated) USP 500mg | Bexus 500 | Shaigan Pharmaceuticals (Pvt) Ltd. | ABC PHARMA SERVICES (PVT) LTD | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00652 | Azathioprine Tablet (uncoated) BP 50 mg | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00697 | Gemcitabine Injection (powder, lyophilized, for solution) USP 1000mg/vial | Biogem 1000 | United Biotech Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/00717 | Capecitabine Tablet USP 500mg | Citabin | United Biotech Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/00759 | Cinnarizine Tablet IP 25mg | Cintigo | Wallace Laboratories Private Limited | Emar Pharma (Pvt) Ltd | Accepted for review |
| MEDREG/2021/00804 | Tacrolimus Capsule USP 5mg | Tacrocord 5 | Concord Biotech Limited | Emerchemie NB (Ceylon) Ltd | Accepted for review |
| MEDREG/2020/00060 | Phenytoin Injectables 250mg/5ml | EPITOIN | VEM Ilaç San. Ve Tic. A.S. | Pharma Associates | Accepted for review |
| MEDREG/2020/00091 | Methylprednisolone Tablet (uncoated) BP 16mg | MYSOLONE 16 | Zee Laboratories | ABC PHARMA SERVICES (PVT) LTD | Accepted for review |
| MEDREG/2020/00107 | Metaraminol Injection (solution for infusion) BP 10mg/ml | TORBAY PHARMACEUTICALS | THE ESSES PHARMCY (PVT.) LTD. | Accepted for review | |
| MEDREG/2020/00136 | Paracetamol Injection (solution for infusion) BP 1.0% w/v | AXAPARA | AXA PARENTERALS LTD | Chamee Chemist | Accepted for review |
| MEDREG/2020/00218 | Glucose Injection (solution for infusion) BP 25.0 w/v | AXADEX D25 | AXA PARENTERALS LTD | Chamee Chemist | Accepted for review |
| MEDREG/2020/00336 | Fenofibrate Tablet (film coated) USP 200 | Treffer Pharmaceuticals | Yaden International Private Limited | Accepted for review | |
| MEDREG/2020/00393 | Cefepime Injectables USP 1GM | MANPIME 1000 | Maan pharmaceuticals limited | P.T.C MEDICAL (PVT) LTD | Accepted for review |
| MEDREG/2020/00397 | Dexamethasone Tablet BP 0.5 mg | De Son | Maxtar Bio-genics | Pharma Associates | Accepted for review |
| MEDREG/2020/00455 | Aciclovir Injection (powder, lyophilized, for solution) BP 250mg | UNIVIR 250 | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2020/00469 | Lidocaine Injection (solution) BP 2% W in V | LIGNOCAINE | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review |
| MEDREG/2020/00472 | Promethazine Tablet BP 25 mg | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2020/00483 | Betahistine Tablet 8mg | Betaserc | MYLAN LABORATORIES SAS | CIC Holdings PLC | Accepted for review |
| MEDREG/2020/00488 | Everolimus Tablet 0.25 mg | J.Duncan Healthcare Pvt. Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review | |
| MEDREG/2020/00492 | Warfarin sodium Tablet (uncoated) USP 2 mg | ZOFARIN 2 | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00504 | Cefalexin Capsules BP 500mg | NOVALEXIN 500 | Innova Captab Pvt Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review |
| MEDREG/2020/00517 | Fexofenadine hydrochloride Suspension 30mg/5ml | Fenofex | Incepta Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review |
| MEDREG/2020/00524 | Prednisolone Tablet BP 5 mg | PE SOLON 5 | Maxtar Bio-genics | Pharma Associates | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00556 | Beclometasone dipropionate Inhalant BP 250mcg/dose | Heilongjiang Province Fulekang Pharmaceutical Co., Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2021/00606 | Cetrimide0.5% w/w SolutionChlorhexidineHydrochloride 0.1% w/w Cream | Septex Antiseptic Cream | Advanced Chemical Industries Limited | CIC Holdings PLC | Accepted for review |
| MEDREG/2021/00607 | Midazolam Injection (solution) BP 5 mg / ml | Ciron Drugs and Pharmaceuticals Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2021/00618 | Haloperidol Oral Solution BP 2mg in 1ml | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00622 | Precipitated Sulfur5%Benzoyl peroxide10% Cream | Persol Forte | Indi Pharma Private Limited | Emar Pharma (Pvt) Ltd | Accepted for review |
| MEDREG/2021/00625 | Aciclovir Tablet (uncoated) USP 200 mg | ACIVIR 200 | Concept Pharmaceuticals Ltd | Softcare International (Pvt) Ltd | Accepted for review |
| MEDREG/2021/00628 | Aciclovir Tablet (film coated) USP 800 | ACIVIR 800 | Concept Pharmaceuticals Ltd. | Softcare International (Pvt) Ltd | Accepted for review |
| MEDREG/2021/00637 | Rosuvastatin Tablet (film coated) 20mg | ROSU 20 | Fredun Pharmaceuticals Limited | George Steuart Health (Pvt.) Ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00645 | Calcium carbonate1250 mgColecalciferol (Vitamin D3)500 IU Capsule, soft gelatin | ZECAL D3 | Indchemie Health Specialities Pvt Ltd | Pharma Associates | Accepted for review |
| MEDREG/2021/00648 | Fluticasone Inhalant BP 125mcg/Dose | Heilongjiang Province Fulekang Pharmaceutical Co., Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2021/00659 | Fentanyl Patch, extended release 50mcg in hour | Fenstud 50 mcg in hour | Rusan Pharma Ltd | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/00666 | Fentanyl Patch, extended release 25mcg in hour | Fenstud 25 mcg in hour | Rusan Pharma Ltd | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/00668 | Allopurinol Tablet BP 100mg | LOGOUT | INGA Laboratories Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/00676 | Fusidic acid Cream BP 2% | Foban Cream | HOE Pharmaceuticals Sdn. Bhd. | Indoscan (Pvt) Ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00678 | Calcium gluconate Injection (solution) USP 10 % W in V | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00681 | Bisoprolol Tablet (film coated) USP 2.5 mg | BRISOTOL 2.5 | Fredun Pharmaceuticals Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/00690 | Hydroxycarbamide Capsules USP 500mg | UNIDREA | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2021/00693 | Calcium carbonate500 mgVitamin D400 U.I. Tablet, chewable | KALZANA 500 | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | To Borderline classification |
| MEDREG/2021/00704 | Bicalutamide Tablet USP 50 mg | CALUT 50 | West-Coast Pharmaceutical Works Ltd | Innogen Lanka Private Limited | Accepted for review |
| MEDREG/2021/00710 | Mefenamic acid Tablet, dispersible 100 mg | Meftal P | Blue Cross Laboratories Pvt Ltd | Sunshine Healthcare Lanka Ltd | Rejected as this dosage form is not needed to the country |
| MEDREG/2021/00710 | Amikacin Injection (solution) USP 500 mg / 2 ml | Ciron Drugs and Pharmaceuticals Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review | |
| MEDREG/2021/00711 | Cefotaxime Injection (powder for solution) USP 0.5g | Reyoung Pharmaceutical Co.,Ltd. | Pharma Associates | Accepted for review | |
| MEDREG/2021/00715 | Domperidone Suppositories 10mg | VOMVIN 10 | Bliss GVS Pharma Ltd | Sunshine Healthcare Lanka Limited | Accepted for review |
| MEDREG/2021/00722 | Finasteride Tablet USP 5 mg | FINA 5 | West-Coast Pharmaceutical Works Ltd | Innogen Lanka Private Limited | Accepted for review |
| MEDREG/2021/00729 | Amoxicillin Oral Suspension BP 125 mg/5 ml | MOXITAM 125 | AMN Life Science Pvt Ltd | Pharma Associates | Accepted for review |
| MEDREG/2021/00736 | Travoprost Ophthalmic solution USP 40mcg/ml | EYPROST | Shaigan Pharmaceuticals (Pvt) Ltd. | ABC PHARMA SERVICES (PVT) LTD | Accepted for review |
| MEDREG/2021/00738 | Mycophenolate mofetil Capsule USP 250mg | MOFECON C 250 | Concord Biotech Limited | Emerchemie NB (Ceylon) Ltd | Accepted for review |
| MEDREG/2021/00746 | Misoprostol Tablet 200 mcg | Steril gene Life Sciences P Ltd | Pharma Associates | Accepted for review | |
| MEDREG/2021/00747 | Flunarizine Tablet 5mg | NORIUM 5 | ESKAYEF PHARMACEUTICALS LIMITED | TRUVIC PRIVATE LIMITED | Accepted for review |
| MEDREG/2021/00754 | Propranolol Injection (solution) USP 1mg in 1ml | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00756 | Lapatinib Tablet 250 mg | Tykerb 250 mg | Sandoz S.R.L. | A. Baur and Co. (Pvt.) Ltd. | Accepted for review |
| MEDREG/2021/00763 | Mecobalamin Capsules 500 mcg | KALMECO 500 µg | PT. KALBE FARMA Tbk. | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00765 | Noradrenaline Injection (solution, concentrate) BP 4mg/2ml | NORALIN | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2021/00772 | Sertraline Hydrochloride Tablet (film coated) BP 50mg | Serin 50 | Unicure Remedies (PVT) Ltd | Emar Pharma (Pvt) Ltd | Accepted for review |
| MEDREG/2021/00776 | Zuclopenthixol deconoate Injection (solution) BP 200 mg in 1 ml | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00778 | Anastrozole Tablet (film coated) USP 1 mg | FEMISTRA 1 mg | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00779 | Risperidone Tablet (film coated) USP 4 mg | RISPONZ 4 | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00798 | Prednisolone Sodium Phosphate Oral Solution BP 5mg in 5ml | REDNI | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/00801 | Salmeterol25 mcgFluticasone50 mcg Inhalational Powder IP | RHEORAN SF 50 | Sun Pharmaceutical Industries Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00803 | Risperidone Tablet (film coated) USP 1 mg | RISPONZ 1 | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00809 | Salmeterol25 mcgFluticasone125 mcg Inhalational Powder IP | RHEORAN SF 125 | Sun Pharmaceutical Industries Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00810 | Losartan potassium Tablet IP 50 mg | Zaart 50 | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product.Site change. Request BE/BW |
| MEDREG/2021/00812 | Meropenem Injection (powder for solution) USP 1 Gm | RONEM 1 G IV Injection | Opsonin Pharma Ltd | Yaden International Private Limited | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00816 | Salmeterol25 mcgFluticasone250 mcg Inhalational Powder IP | RHEORAN SF 250 | Sun Pharmaceutical Industries Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00817 | Meropenem Injection (powder for solution) USP 500mg | RONEM 500 MG IV INJECTION | Opsonin Pharma Ltd | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/00818 | Nepafenac Ophthalmic suspension 0.1 percent w/w | Nevanac | sa Alcon-Couvreur nv | A. Baur and Co. (Pvt.) Ltd. | Accepted for review |
| MEDREG/2021/00826 | Timolol Ophthalmic solution BP 0.5% w/v | T LOL | Divine Laboratories PVT. Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review |
| MEDREG/2021/00830 | Mebeverine hydrochhloride Tablet BP 135 mg | Treffer Pharmaceuticals | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00831 | Pantoprazole Delayed-Release Tablets USP 40 mg | PANTAKIND 40 | Mankind Pharma Ltd - Unit II | Hemas Pharmaceuticals Pvt Ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00835 | Linezolid Tablet 600 mg | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/00861 | Dapoxetine Hydrochloride Tablet 30 mg | DAPON 30 | West-Coast Pharmaceutical Works Ltd | Innogen Lanka Private Limited | Accepted for review |
| MEDREG/2021/00893 | Pregabalin Capsules 150mg | THEORICA 150 | Theon Pharmaceuticals Ltd | Slim Pharmaceuticals Pvt ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00897 | Oxymetazoline Nasal drops USP 0.05 % w/v | Oxina | Megasys Biotek Pvt.ltd | Pharmatec Pvt Ltd | Accepted for review |
| MEDREG/2021/00904 | Montelukast Chewable Tablets 5 mg | Glemont CT 5 | Glenmark Pharmaceuticals Limited | Hemas Pharmaceuticals Pvt Ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00921 | Levetiracetam Tablet (film coated) 500mg | LETRAM 500 | Hetero Labs Limited, Unit III | Mansel (Ceylon) (Private) Limited | Accepted for review |
| MEDREG/2021/00922 | Donepezil hydrochloride Tablet (film coated) USP 10mg | ALZER 10 | Hetero Labs Limited, Unit V | Mansel (Ceylon) (Private) Limited | Accepted for review |
| MEDREG/2021/00956 | Desonide Cream 0.05% w/w | Dosetil Cream | Glenmark Pharmaceuticals Limited - Unit II | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00959 | Moxifloxacin Ophthalmic solution 0.05 W/v | Vigamox | sa Alcon-Couvreur nv | A. Baur and Co. (Pvt.) Ltd. | Accepted for review |
| MEDREG/2021/00961 | Fluconazole Tablet 150mg | INGAZOLE | INGA Laboratories Private Limited | George Steuart Health (Pvt.) Ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00963 | Everolimus Tablet, dispersible 10 mg | Afinitor | Novartis Pharma Stein AG- Switzerland | A. Baur and Co. (Pvt.) Ltd. | Accepted for review |
| MEDREG/2021/00970 | Irbesartan Tablet (uncoated) USP 150 mg | IROVEL 150 | Sun Pharma Laboratories Limited, | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2021/00976 | Clindamycin Injection (solution) USP 600mg/4ml | CLINDATEC 600 | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2021/00979 | Amlodipine Tablet (uncoated) USP 10 mg | AMLOSUN 10 | Sun Pharma Laboratories Limited, | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW( Site change) |
| MEDREG/2021/00980 | Albendazole Tablet IP 400mg | ALBEX 400 | Kniss Laboratories Pvt Ltd | Pharma Associates | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/00981 | Dopamine hydrochloride Injection (solution for infusion) USP 200mg/5ml | DOPAR | Samarth Life Sciences Pvt Ltd | Pharma Associates | Accepted for review |
| MEDREG/2021/00991 | Methoxsalen Tablet (uncoated) 10mg | MELADERM | INGA Laboratories Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/00993 | Methotrexate Injection (solution) BP 100 mg per 1 ml | Methofast 1000 | Neon Laboratories Limited | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/01001 | Hyoscine butylbromide Tablet (film coated) BP 10mg | BELLOID | INGA Laboratories Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/01002 | Lenalidomide Capsule 25mg | LINADEX 25 | Hetero Labs Limited, Unit V | Mansel (Ceylon) (Private) Limited | Accepted for review |
| MEDREG/2021/01003 | Amoxicillin500mgClavulanic acid125mg Tablet USP | NUMOLAV 625mg | Saitech Medicare Pvt. Limited | Slim Pharmaceuticals Pvt ltd | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/01011 | Hydrocortisone Injection (powder for solution) USP 100mg | H CORT 100 | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2021/01021 | Ruxolitinib Tablet 20mg | RUXOVEON 20 | AEON FORMULATIONS PRIVATE LIMITED | LANKA THERAPEUTICS (PVT) LTD | Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2021/01032 | Cefotaxime Injection (powder for solution) USP 1g | Reyoung Pharmaceutical Co.,Ltd. | Pharma Associates | Accepted for review | |
| MEDREG/2021/01038 | Sodium chloride Ophthalmic solution USP 5% w/v | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/01040 | Brimonidine Eye Drops 0.15 % W/V | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/01043 | Canagliflozin Tablet (film coated) 100mg | CANAFLIN 100 | Hetero Labs Limited, Unit V | Mansel (Ceylon) (Private) Limited | Accepted for review |
| MEDREG/2021/01051 | Phentoxifyline Tablet (film coated) USP 400 mg | MECTAL | Mercury Laboratories Limited | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/01055 | Mitomycin Injection (powder, lyophilized, for solution) USP 2mg | LYOMIT 2 | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2021/01056 | Sodium Hyaluronate Injection (solution) 20 mg/ 2.0 ml | HYAL FORTE Injection | Shin Poong Pharmaceutical Co., Ltd | Pharma Associates | Accepted for review |
| MEDREG/2021/01063 | Penicillamine Capsules USP 250mg | Dagon Pharmaceuticals (Pvt) Ltd | Eurochem Biotech Private Limited | Accepted for review | |
| MEDREG/2021/01083 | Nilotinib Capsule 150mg | NILTIB 150 | Hetero Labs Limited, Unit V | Mansel (Ceylon) (Private) Limited | Accepted for review |
| MEDREG/2021/01089 | Naloxone Injection (solution) USP 400 mcg/ml | NEX® 400 | Neon Laboratories Limited | Yaden International Private Limited | Accepted for review |
| MEDREG/2021/01110 | Mometasone furoate Cream IP 0.1% w/w | MTAZ | Indi Pharma Private Limited | Emar Pharma (Pvt) Ltd | Accepted for review |
| MEDREG/2021/01124 | Mebeverine hydrochhloride Capsule, extended release 200mg | Colospas MR | Nabiqasim Industries Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review |
| MEDREG/2021/01128 | Donepezil hydrochloride Tablet (film coated) USP 5 mg | Treffer Pharmaceuticals | Yaden International Private Limited | Accepted for review | |
| MEDREG/2021/01146 | Ticagrelor Tablet (film coated) 90mg | Anplag 90 | PHARMEVO PVT LTD | CIC Holdings PLC | Accepted for review |
| MEDREG/2021/01155 | Beclometasone dipropionate Pressurised Inhalation BP 250 mcg/ actuation | Ibicar 250 | Glenmark Pharmaceuticals Limited ( Unit III) | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00239 | Gliclazide Tablet, modified release 30mg | Remicron MR 30 | Sun Pharmaceutical Industries Limited | Emerchemie NB (Ceylon) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00260 | Cefotaxime Injection (powder for solution) USP 1000mg | Oritaxim 1000 | Cadila Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2020/00398 | Clotrimazole Cream BP 1% w/w | MYCORIL | Remedica Limited | Kandana Food And Drugs (PVT) LTD. | Accepted for review.Existing product |
| MEDREG/2020/00402 | Diclofenac sodium Tablet, enteric coated BP 25mg | ALMIRAL 25mg | Medochemie Ltd Central factory | Associated Laboratories (Private) Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00446 | Miconazole Oral paste BP 2% | Decozol Oral Gel | HOE Pharmaceuticals Sdn. Bhd. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00574 | Timolol Eye Drops BP 0.5% w/v |
TIMATE |
AXA PARENTERALS LTD | ABC PHARMA SERVICES (PVT) LTD | Accepted for review.Existing product |
| MEDREG/2020/00587 | Bromhexine 4mg Phenylephrine hydrochloride2.5mg Guaifenesin50mg Oral liquid | FLEMNIL Expectorant Liquid | Raptakos, Brett and Co. Ltd | Pharma Associates | Accepted for review.Existing product |
| MEDREG/2021/00627 | Mupirocin Ointment BP 2% | Trego | Incepta Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product |
| MEDREG/2021/00643 | Gabapentin Capsule USP 300mg | GABAFRED 300 | Fredun Pharmaceuticals Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00646 | Aluminium hydroxide 250mg in 5ml BP Magnesium hydroxide250mg in 5ml BP Simeticone50mg in 5ml BP Suspension USP | Coolgel | McW Heathcare (P) Ltd | TRANZ PHARMA HOLDINGS (PRIVATE ) LIMITED | Accepted for review.Existing product |
| MEDREG/2021/00813 | Atorvastatin Tablet (film coated) USP 20mg | HYPOLIP 20 | Hetero Labs Limited, Unit V | Mansel (Ceylon) (Private) Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00246 | Xylometazoline hydrochloride Nasal drops USP 0.05%w/v | Decon Paediatric Nasal Drops | Cadila Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2020/00348 | Gliclazide Tablet, modified release 30 mg | Glix MR 30 | Wallace Laboratories Private Limited | Emar Pharma (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00365 | Abiraterone acetate Tablet USP 250 mg | BDRON | BDR Pharmaceuticals International Pvt Ltd | Pharma Associates | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00379 | Montelukast Tablet (film coated) USP 10mg | AIREEZ | PHARMEVO PVT LTD | CIC Holdings PLC | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00380 | Losartan potassium50mgHydrochlorothiazide12.5mg Tablet (film coated) USP | NORMOZIDE | CCL Pharmaceuticals Pvt Ltd | CIC Holdings PLC | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00401 | Docetaxel Injection (solution) USP 10mg/ml | ZYTAX 20 | Zydus Hospira Oncology Pvt. Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00413 | Cetirizine hydrochloride Oral Solution BP 5 mg/ 5 ml | Cetzed | G.D. Laboratories India Private Limited | Lifeline Pharmaceuticals (Pvt) Limited | Accepted for review.Existing product |
| MEDREG/2020/00432 | Calcium carbonate1250mgVitamin D250IU Tablet BP | CIANCAL 500 | Cian Healthcare Pvt. Ltd, | Slim Pharmaceuticals Pvt ltd | To Borderline classification |
| MEDREG/2020/00438 | Ringer's lactate solution Intravenous Infusion USP USP 39 | Lactated Ringer's Solution (Hartmann's Solution) | EURO-MED Laboratories Phil.,Inc. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00445 | Docusate sodium Ear drops 0.5% W/V | WAXSOL | Medical and cosmetic products company Ltd. (Riyadh Pharma) | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00456 | Fexofenadine hydrochloride Tablet (film coated) USP 120mg | Fexil 120 | Sai Mirra Innopharm Private Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00462 | Salicylic acid Solution BP 17% | Ellgy Corns And Warts | HOE Pharmaceuticals Sdn. Bhd. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00470 | Famotidine Tablet USP 20 mg | Labotine 20 | Laborate Pharmaceuticals India Limited | Pharma Associates | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00474 | Cefuroxime Injection (powder for solution) USP 750mg | Cefogen 750 | Cadila Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2020/00495 | Pregabalin Capsules 75 mg | Lyrica | Pfizer Manufacturing Deutschland GmbH | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00500 | Vitamin C (Ascorbic acid) Powder 1000mg | NAT C Ester | Mega Life Sciences Public Company Limited | A. Baur and Co. (Pvt.) Ltd. | Accepted for review.Existing product |
| MEDREG/2020/00509 | Telmisartan Tablet (uncoated) USP 40mg | Teli 40 | Cadila Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00513 | Azithromycin Tablet USP 500mg | AZITHRIN 500 | Theon Pharmaceuticals Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00569 | Gliclazide Tablet, modified release 60 mg | DIANORM OD 60 | Micro Labs Limited | Micro Mega Lanka (Pvt) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00592 | Esomeprazole Tablet 40mg | ESOTAC 40 | Navana Pharaceuticals Ltd | Darley Butler and Co Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00595 | Meropenem Injection (powder for solution) USP 500mg | MERONASH 500 | Shamshree Lifesciences Ltd | Omacx Healthcare Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00596 | Meropenem Injection (powder for solution) USP 1000mg | MERONASH 1000 | Shamshree Lifesciences Ltd | Omacx Healthcare Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00600 | Amphotericin B Injection (liposomal) IP 50mg/Vial | AMBILIP | United Biotech Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product |
| MEDREG/2021/00610 | Amoxicillin500mgClavulanic acid125mg Tablet USP | CHIMOX CV 625 | ChirosPharma | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product |
| MEDREG/2021/00611 | Chlorhexidine Gel 0.1% w/w | Oralon Dental Gel | Advanced Chemical Industries Limited | CIC Holdings PLC | Accepted for review.Existing product |
| MEDREG/2021/00612 | Sodium chloride Injection (solution) USP 0.9% | Sodium Chloride Injection | EURO-MED Laboratories Phil.,Inc. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2021/00638 | Betahistine Tablet 16mg | Betaserc | MYLAN LABORATORIES SAS | CIC Holdings PLC | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00640 | Bosentan Tablet 62.5 mg | Bosentas 62.5 | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00651 | Acarbose Tablet (uncoated) USP 50 mg | Diabose 50 | Micro Labs Limited | Micro Mega Lanka (Pvt) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00669 | Albendazole Tablet USP 400mg | Lokaben 400 | J.Duncan Healthcare Pvt. Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00679 | Esomeprazole Capsule USP 40mg | ESSO 40 | Shaigan Pharmaceuticals (Pvt) Ltd. | ABC PHARMA SERVICES (PVT) LTD | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00688 | Amoxicillin500mgClavulanic acid125mg Tablet (film coated) USP | CLAVOTEC 625 | United Biotech Private Limited | Klintas Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00695 | Gemcitabine Injection (powder, lyophilized, for solution) USP 200mg/vial | Biogem 200 | United Biotech Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product |
| MEDREG/2021/00709 | Amoxicillin875 mgClavulanic acid125 mg Tablet USP | INDCLAV 1000 | Indchemie Health Specialities Pvt Ltd | Pharma Associates | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00714 | Cisplatin Injection (concentrate, solution for infusion) BP 50mg/50mL | Uniplatin 50 | United Biotech Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product |
| MEDREG/2021/00721 | Metoclopramide Injection (concentrate, solution for infusion) BP 5mg/ml | pharmafabrikon, Unit ll | NOVACHEM LANKA PRIVATE LIMITED | Accepted for review.Existing product | |
| MEDREG/2021/00733 | Losartan potassium Tablet USP 50mg | LARA 50 | Alkem Laboratories Limited | Emerchemie NB (Ceylon) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00735 | Methotrexate Injection (solution) BP 50 mg / 2 ml | Emthex 50 | Khandelwal Laboratories Pvt. Ltd. | Ceyoka(Pvt)Ltd | Accepted for review.Existing product |
| MEDREG/2021/00737 | Fluoxetine Capsules USP 20 mg | DAWNEX | Micro Labs Limited | Micro Mega Lanka (Pvt) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00742 | Lithium carbonte Tablet (film coated) USP 250mg | HYPNOLITH 250 | pharmafabrikon, Unit ll | NOVACHEM LANKA PRIVATE LIMITED | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00773 | Dexamethasone Injection (concentrate, solution for infusion) BP 4mg/ml | pharmafabrikon, Unit ll | NOVACHEM LANKA PRIVATE LIMITED | Accepted for review.Existing product | |
| MEDREG/2021/00792 | Sitagliptin Tablet BP 50mg | Sitagil 50 | Incepta Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00849 | Disodium Hydrogen Citrate Oral liquid 1.37 gm/ 5ml | Cital | Indoco Remedies Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00854 | Telmisartan Tablet USP 40mg | INNOTEL 40 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00858 | Telmisartan Tablet USP 20mg | INNOTEL 20 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00859 | Pregabalin Capsules 75mg | NOVAPREG 75 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00864 | Montelukast Tablet 5mg | VENTOKAST 5 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00865 | Montelukast Tablet 10mg | VENTOKAST 10 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00866 | Telmisartan Tablet USP 20mg | TELSAR 20 | Theon Pharmaceuticals Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00873 | Amoxicillin125mg per 5mlClavulanic acid31.25mg per 5ml Powder, for oral suspension BP | Moxiclav 156.25mg/5ml | Medochemie Ltd - Ampoule Injectable facility and Factory B - oral facility | Associated Laboratories (Private) Limited | Accepted for review.Existing product |
| MEDREG/2021/00876 | Oxymetazoline Nasal drops USP 0.025 % w/v | Oxina P | Megasys Biotek Pvt.ltd | Pharmatec Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00884 | Gentamicin Eye and Ear drops 0.3% W/V | Bactigen | FDC LIMITED | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2021/00887 | Ciclosporin Emulsion 0.05% w/v ( 0.5 mg/ml) | CYPORIN | Aristopharma LTD | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00898 | Amoxicillin250mgClavulanic acid125mg Tablet (film coated) USP | NUMOLAV 375 | Saitech Medicare Pvt. Limited | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00908 | Ipratropium bromide Respiratory solution 250 mcg /1 ml | Ipravent Respules | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product |
| MEDREG/2021/00920 | Losartan potassium Tablet (film coated) USP 25 mg | ANGIZAAR 25 | Micro Labs Limited | Micro Mega Lanka (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00945 | Miconazole2% w/wFluocinolone acetonide0.01% w/w Ointment | Emzole F | Central Drugs and Pharmaceuticals | Pharma Associates | Accepted for review.Existing product |
| MEDREG/2021/00951 | Fexofenadine hydrochloride Tablet (film coated) USP 180 mg | HISTAFREE–180 | Akums Drugs and Pharmaceuticals Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00964 | Amoxicillin250mgClavulanic acid125mg Tablet USP | CHIMOX CV 375 | ChirosPharma | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00967 | Omeprazole Delayed-Release Capsules USP 20 mg | OSKAR – 20 | Akums Drugs and Pharmaceuticals Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00989 | Clotrimazole Lotion BP 1% | Candazole Lotion | HOE Pharmaceuticals Sdn. Bhd | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2021/01004 | Betamethasone Dipropionate0.064% w/vSalicylic acid2.0% w/v Lotion USP |
Beprosalic Lotion | HOE Pharmaceuticals Sdn. Bhd. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2021/01014 | Folic acid Tablet (uncoated) BP 1mg | FOLVIT 1 | Bafna Pharmaceuticals Ltd | Pharma Associates | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01028 | Metformin Tablet (film coated) BP 850 mg | MELMET 850 | Micro Labs Limited | Micro Mega Lanka (Pvt) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01044 | Albendazole Tablet, chewable 400 mg | Endworm Tablets | Bafna Pharmaceuticals Ltd | Pharma Associates | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01065 | Betamethasone Cream BP 0.1% w/w | Betasone Cream | Hovid Bhd | Mansel (Ceylon) (Private) Limited | Accepted for review.Existing product |
| MEDREG/2021/01107 | Ofloxacin Ophthalmic solution USP 3 mg/ml (0.3% w/v) | EXOCIN | Piramal Pharma Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/01148 | Spironolactone Tablet (uncoated) BP 25 | SPILLAR 25 | Centaur Pharmaceuticals Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01150 | Formoterol fumarate6 mcg Budesonide100 mcg Pressurised Inhalation | Foracort 100 Inhaler | Cipla Ltd | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product |
| MEDREG/2021/01152 | Beclometasone dipropionate Pressurised Inhalation BP 100 mcg / Actuation | Ibicar 100 | Glenmark Pharmaceuticals Limited ( Unit III) | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/01161 | Doxycycline Capsules BP 100 mg | Alldox | Lincoln Pharmaceuticals ltd | Pharmatec Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00102 | Tamoxifen Tablet (film coated) BP 20mg | Nolvadex D | AstraZeneca UK Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00109 | Iopromide Injection (solution) 768.86mg (equal to 370mg of Iodine) 370 mgI/1ml | Ultravist 370 | Bayer AG | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00300 | Rosuvastatin Tablet (film coated) 20mg | X Plended 20mg Tablet | PHARMEVO PVT LTD | CIC Holdings PLC | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00376 | Ferrous Ascorbate(Eq.to 30 mg of Elemental Iron) Folic acid550 mcg Oral Suspension | Chelferry | Leben Laboratories Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00436 | Glimepiride Tablet (uncoated) USP 4mg | GLIMITAB 4 | Centaur Pharmaceuticals Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00575 | MethylprednisoloneSodium Succinate Injectables USP 500 mg | METRITE | Gufic Biosciences Ltd | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product |
| MEDREG/2020/00584 | Clomifene citrate Tablet (uncoated) BP 50 mg | FOLISTIM 50 | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00594 | Isosorbide mononitrate Tablet, extended release USP 60mg | SOLOTRATE SR 60 | Cadila Healthcare Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00649 | Atenolol Tablet BP 50mg | Tenolol 50 | IPCA Laboratories Ltd | Emar Pharma (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00663 | Terbutaline Tablet USP 2.5 | Brethin | Platinum Pharmaceuticals Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00685 | Atenolol Tablet (film coated) BP 50mg | Agiten 50 | Agio Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00718 | Hydrocortisone0.5%Clioquinol3% Cream (topical) BP | GALENTIC PHARMA INDIA PRIVATE LIMITED | Ceyoka(Pvt)Ltd | Accepted for review.Existing product | |
| MEDREG/2021/00730 | Ondansetron Tablet, orally disintegrating USP 4mg | Emistat FT 4mg | Healthcare Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product |
| MEDREG/2021/00799 | Brimonidine Ophthalmic solution 0.15 % w/v (1.5 mg/mL ) | ALPHAGAN P | Allergan Sales LLC | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00069 | Betahistine Tablet BP 8mg | HISTAVERT 8 | Pulse Pharmaceuticals Pvt. Ltd | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00087 | Amoxicillin250Clavulanic acid125 Tablet | Curam 375 | Sandoz GmbH | A. Baur and Co. (Pvt.) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00098 | Promethazine Tablet BP 25 mg | Promezin 25 Tablet | Leben Laboratories Pvt.Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00109 | Iopromide Injection (solution) 768.86mg (equal to 370mg of Iodine) 370 mgI/1ml | Ultravist 370 | Bayer AG | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00117 | Amoxicillin500mgClavulanic acid125mg Tablet (film coated) BP | MOXICLAV 625mg | Medochemie Ltd (Factory B) | Associated Laboratories (Private) Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00138 | Sulfamethoxazole400mgTrimethoprim80mg Tablet (uncoated) BP | MEGATRIM | Fourrts (India) Laboratories Pvt. Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00151 | Atorvastatin Tablet (film coated) 10mg | LIPLO 10 | Globe Pharmaceuticals Ltd | Tabrane Healthcare (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00221 | Tetracycline Ointment (topical) USP 3% W/W | Galentic Pharma (India) Private Limited | Ceyoka(Pvt)Ltd | Accepted for review.Existing product | |
| MEDREG/2020/00287 | Diclofenac sodium Suppositories 25mg | DICLOVIN 25 | BLISS GVS PHARMA LIMITED | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2020/00322 | Ciprofloxacin Eye and Ear drops 0.3% w/v | I CIP | AXA PARENTERALS LTD | ABC PHARMA SERVICES (PVT) LTD | Accepted for review.Existing product |
| MEDREG/2020/00362 | Montelukast Tablet (film coated) 10 mg | Montiget | Getz Pharma Pvt Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00363 | Retinol4000 I.U.Colecalciferol (Vitamin D3)400 I.U.Vitamin E (Tocopherol)5 mgThiamine (Vitamin B1)3 mgRiboflavin (Vitamin B2)1.2 mgPyridoxine (Vitamin B6)1 mgDexpanthenol5 mgNicotinamide25 mgVitamin C (Ascorbic acid)50 mgCyanocobalamin3 mcg Syrup | Hovite Syrup | Raptakos, Brett and Co. Ltd | Pharma Associates | To Borderline classification |
| MEDREG/2020/00366 | Sitagliptin Tablet (film coated) USP 50 mg | SITAGLIP 50 | The ACME Laboratories Ltd. | Mega Pharma (Pvt) Ltd. | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00406 | Benzoyl peroxide Gel BP 2.5% W/W | Persol AC 2.5 | Indi Pharma Private Limited | Emar Pharma (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00410 | Loratadine Tablet (uncoated) USP 10mg | LORITEX 10 | Agio Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00437 | Pethidine Injection (solution) BP 50MG/ML | VERPAT 50 | Verve Human Care Laboratories | Leader Pharma Agency (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00442 | Clotrimazole Oral Solution 1% w/v | CANDID | Glenmark Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product |
| MEDREG/2020/00449 | Pantoprazole Capsules 40mg | PANTOZIM 40 | ZIM LABORATORIES LIMITED | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00461 | Salmeterol 50mcgFluticasone 250mcg Powder, metered | Seretide Accuhaler Diskus | Glaxo Wellcome Production | GlaxoSmithKline Pharmaceuticals (Private) Limited | Accepted for review.Existing product |
| MEDREG/2020/00465 | Salmeterol 50mcgFluticasone 500mcg Powder, metered | Seretide Accuhaler Diskus | Glaxo Wellcome Production | GlaxoSmithKline Pharmaceuticals (Private) Limited | Accepted for review.Existing product |
| MEDREG/2020/00466 | Griseofulvin Tablet BP 500 mg | GRISEBEN 500 TABLET | Leben Laboratories Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00480 | Clarithromycin Tablet (film coated) USP 500mg | CLARILET 500 | ZIM LABORATORIES LIMITED | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2020/00494 | Ciprofloxacin Eye and Ear drops 0.3% w/v | Beuflox Eye/Ear Drops | Incepta Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product |
| MEDREG/2020/00505 | Fusidic acid Cream (topical) 20 mg/g | FUCIDIN CREAM | Leo Laboratories Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00511 | Sodium Fusidate Ointment (topical) 20 mg/g ( 2 % ) | FUCIDIN® OINTMENT | Leo Laboratories Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2020/00521 | Clobazam Tablet (uncoated) BP 10MG | VERCLOB | Verve Human Care Laboratories | Leader Pharma Agency (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00522 | Metoprolol Tablet, film coated, extended release USP 50 mg | REVELOL XL 50 | IPCA Laboratories Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00525 | Sodium Fusidate Tablet (film coated) 250 mg | FUCIDIN TABLETS | Laboratories Leo | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00560 | Candesartan Tablet 8 mg | Advant | Getz Pharma (Pvt) Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00563 | Propanol45 g Propanol30 g Liquid (topical) | SANISCRUB M | Sirmaxo Chemicals Pvt. Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product |
| MEDREG/2020/00564 | Vildagliptin Tablet 50mg | Redia 50mg | Healthcare Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2020/00594 | Isosorbide mononitrate Tablet, extended release USP 60mg | SOLOTRATE SR 60 | Cadila Healthcare Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00621 | Betahistine Tablet 24 | Betaserc | MYLAN LABORATORIES SAS | CIC Holdings PLC | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00661 | Simvastatin Tablet (film coated) USP 10 mg | Zosta 10 | Medibios Laboratories Limited, | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00682 | Ondansetron Tablet (film coated) USP 4mg | Vomiz 4 | Cadila Healthcare Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00684 | Ondansetron Tablet (film coated) USP 8mg | Vomiz 8 | Cadila Healthcare Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00691 | Atenolol50mgChlortalidone12.5mg Tablet BP | Tenoric 50 | IPCA Laboratories Ltd | Emar Pharma (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00696 | Moxifloxacin Intravenous Infusion 400 mg/ 250 ml | MOXIGET IV | Getz Pharma (Pvt) Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00727 | Triamcinolone Acetonide Injection (suspension) USP 40mg | TRIAM Injection | Shin Poong Pharmaceutical Co., Ltd | Pharma Associates | Accepted for review.Existing product |
| MEDREG/2021/00740 | Beclometasone dipropionate0.05%Salicylic acid3% Ointment (topical) | Betacyclic Ointment | Agio Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product |
| MEDREG/2021/00769 | Lidocaine hydrochloride Gel IP 2% W/V | Ciron Drugs and Pharmaceuticals Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product | |
| MEDREG/2021/00777 | Bromhexine Tablet 8mg | Solvin | IPCA Laboratories Ltd | Emar Pharma (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00790 | Efavirenz Tablet (film coated) USP 600mg | ESTIVA 600 | Hetero Labs Limited, Unit III | Mansel (Ceylon) (Private) Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00836 | Telmisartan Tablet USP 80mg | Teli 80 | Cadila Pharmaceuticals Limited | Sunshine Healthcare Lanka Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00838 | Atorvastatin Tablet USP 10mg | Choltrol 10 | Agio Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00843 | Ciclosporin Emulsion 0.05 % ( 0.5 mg/g ) | RESTASIS | Allergan Sales LLC | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00846 | Rosuvastatin Tablet 5mg | ROSUNOVA 5 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00850 | Rosuvastatin Tablet 10mg |
ROSUNOVA 10 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00853 | Losartan potassium Tablet USP 50mg | LOSARIDE 50 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00856 | Amlodipine Tablet USP 5 mg | Amlopres 5 | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00857 | Omeprazole Delayed-Release Capsules USP 20mg | INNOCID 20 | Innova Captab | Slim Pharmaceuticals Pvt ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00869 | Atorvastatin Tablet (film coated) 10 mg | LIPIZIM 10 | ZIM LABORATORIES LIMITED | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00911 | Fluconazole Capsule BP 50mg | Candinil 50 | Healthcare Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00928 | Fexofenadine hydrochloride Tablet USP 180 mg | Algitab 180 | Platinum Pharmaceuticals Private Limited | George Steuart Health (Pvt.) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00933 | Losartan potassium Tablet (film coated) USP 50mg | COSART 50 | ZIM LABORATORIES LIMITED | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00938 | Ketorolac Ophthalmic solution 0.45 % (4.5 mg/ ml) | ACUVAIL | Allergan Sales LLC | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00957 | Esomeprazole Capsule USP 40mg | Sergel 40 | Healthcare Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00965 | Paracetamol Tablet (uncoated) BP 500 mg | PARAGON | Cadila Healthcare Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00972 | Dorzolamide2%Timolol0.5% Eye Drops | Zolicheck T | Indoco Remedies Limited | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product |
| MEDREG/2021/00974 | Diclofenac sodium Tablet, enteric coated BP 50 mg | ARNIL 50 |
Brookes Pharma (Pvt) Ltd | Hemas Pharmaceuticals Pvt Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/00988 | Ketoconazole Cream USP 2% | Dezor Cream | HOE Pharmaceuticals Sdn. Bhd. | Indoscan (Pvt) Ltd | Accepted for review.Existing product |
| MEDREG/2021/01007 | Amoxicillin Capsules BP 500 mg | Moxileb 500 Capsule | Leben Laboratories Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01062 | Formoterol fumarate6 mcg Budesonide200 mcg Dry Powder Capsules for Inhalation | Foracort 200 DP caps | Cipla Limited | BREATHE FREE LANKA (PRIVATE) LIMITED | Accepted for review.Existing product |
| MEDREG/2021/01070 | Indometacin Capsules BP 25 mg | Indol Capsule | Leben Laboratories Pvt Ltd | Ceyoka(Pvt)Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01100 | Telmisartan Tablet (uncoated) USP 20mg | TELCARD 20 | ZIM LABORATORIES LIMITED | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review.Existing product.Request BE/BW |
| MEDREG/2021/01111 | Domperidone Tablet BP 10mg | Omidone 10 | Incepta Pharmaceuticals Ltd | Citihealth Imports Private Limited | Accepted for review.Existing product.Request BE/BW |
MEC decision for the medicine applications received via e-NMRA system from 25.01.2021 to 21.02.2021.
| Reference No | Name of the Product | Brand Name | Manufacturer | Importer | MEC decision |
|---|---|---|---|---|---|
| MEDREG/2020/00136 | Paracetamol Injection (solution for infusion) BP 1.0% w/v |
AXAPARA |
AXA PARENTERALS LTD, INDIA |
Chamee Chemist |
Accepted for review. Price to be negotiated. |
| MEDREG/2020/00194 |
Cefuroxime axetil Tablet USP 250mg |
OZAX 250 |
Saga Lifesciences Limited, India |
Klintas Pvt Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00230 |
Tobramycin0.3Dexamethasone0.1 Ophthalmic ointment |
TOBRADEX |
S.A Alcon Couvreur NV, Belgium |
A. Baur and Co. (Pvt.) Ltd. |
Accepted for review |
| MEDREG/2020/00282 |
Adapalene Gel 0.1% w/w |
Adaferin |
LABORATORIES GALDERMA, France |
Sunshine Healthcare Lanka Limited |
Accepted for review |
| MEDREG/2020/00408 |
Dipyridamole Tablet (film coated) BP 75mg |
PERAZODIN 75 |
Remedica Limited, Cyprus |
Kandana Food And Drugs (PVT) LTD. |
Rejected informing that this strength is not need and healthcare care need of the country can be fulfilled by the existing products in Sri Lanka |
| MEDREG/2020/00417 |
Amoxicillin Capsule USP 250mg |
Theomox 250 |
Theon Pharmaceuticals Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2020/00459 |
Ceftazidime Injection (powder for solution) USP 1000mg |
THEOZIDE 1000 |
Theon Pharmaceuticals Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review (excisting product). |
| MEDREG/2020/00477 |
Fluoxetine Capsule BP 20mg |
Magrilan 20mg |
Medochemie Ltd Central factory,Cyprus |
Associated Laboratories (Private) Limited |
Accepted for review (excisting product). |
| MEDREG/2020/00489 |
Warfarin sodium Tablet (uncoated) USP 1 mg |
ZOFARIN 1 |
Cadila Healthcare Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00499 |
Nifedipine Tablet, sustained release 20mg |
NEPIN SR 20 |
Lincoln Pharmaceuticals ltd,India |
Pharmatec Pvt Ltd |
Accepted for review (excisting product). |
| MEDREG/2020/00512 |
Methylene Blue Injection (solution) 100 mg/10 ml |
BLUMET |
VEM Ilaç San. Ve Tic. A.S, Turkey |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00514 |
Fluconazole Capsule 150 mg |
DIFLUVID |
Hovid Bhd, Malaysia |
Mansel (Ceylon) (Private) Limited |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2020/00527 |
Telmisartan Tablet USP 40mg |
TELSAR 40 |
Theon Pharmaceuticals Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2020/00578 |
Fluvoxamine maleate Tablet (film coated) 50mg |
LUVOX 50 |
MYLAN LABORATORIES SAS, France |
CIC Holdings PLC |
Accepted for review (excisting product). |
| MEDREG/2020/00583 |
Gadoteric acid Injection (solution) 0.5mmol/ml |
CLARISCAN |
GE Healthcare AS, Norway |
Sunshine Healthcare Lanka Ltd |
Accepted for review |
| MEDREG/2020/00585 | Erlotinib Tablet 25mg |
N/A |
Shilpa Medicare Limited,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00590 |
Amoxicillin Capsules BP 500 mg |
MOXILINK 500 |
Lincoln Pharmaceuticals ltd,India |
Pharmatec Pvt Ltd |
Accepted for review (excisting product). |
| MEDREG/2021/00601 |
Mefenamic acid Tablet BP 250 mg |
MEFTAR 250 |
Maxtar Bio-genics,India |
Pharma Associates |
Rejected informing that this strength is not need and healthcare care need of the country can be fulfilled by the existing products in Sri Lanka |
| MEDREG/2021/00608 |
Sildenafil Tablet USP 100mg |
THEOGRA 100 |
Theon Pharmaceuticals Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review (excisting product). |
| MEDREG/2021/00615 |
Chlorhexidine Mouth Wash 0.2% w/v |
Oralon Mouth Rinse |
Advanced Chemical Industries Limited , Bangladesh |
CIC Holdings PLC |
Accepted for review (excisting product). |
| MEDREG/2021/00624 |
Domperidone Tablet BP 10mg |
Costi 10mg |
Medochemie Ltd Central factory,Cyprus |
Associated Laboratories (Private) Limited |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2021/00641 |
Azithromycin Tablet (film coated) USP 500mg |
AZITEC 500 |
United Biotech Private Limited,India |
Klintas Pvt Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00117 |
Amoxicillin500mgClavulanic acid125mg Tablet (film coated) BP |
MOXICLAV 625mg |
Medochemie Ltd (Factory B),Cyprus |
Associated Laboratories (Private) Limited |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2020/00266 |
Prazosin Tablet, modified release 5 mg |
Minipress XL |
Manufactured By Pfizer Pharmaceuticals LLC and Packed and Released By Fareva Amboise. France |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00507 |
Fexofenadine hydrochloride Tablet (film coated) USP 180mg |
FEXORIL 180 |
ZIM LABORATORIES LIMITED,India |
Tabrane Pharmaceuticals (Pvt) Ltd |
Accepted for review (excisting product). Request BE/BW data |
| MEDREG/2020/00520 |
Metoprolol Tablet, film coated, extended release USP 25 mg |
REVELOL XL 25 |
IPCA Laboratories Ltd,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review.(excisting product). |
| MEDREG/2020/00528 |
Metoprolol Tablet, film coated, extended release USP 100 mg |
REVELOL XL 100 |
IPCA Laboratories Ltd,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review.(excisting product). |
| MEDREG/2020/00534 |
Streptokinase Injection (powder for solution for infusion) BP 1 500 000 IU |
STPASE |
Cadila Pharmaceuticals Limited,India |
Sunshine Healthcare Lanka Limited |
Accepted for review.(excisting product). |
| MEDREG/2020/00565 |
Acetylcysteine Injection (solution) USP 200 mg / ml |
CIROCYST 200 |
Ciron Drugs and Pharmaceuticals Pvt Ltd,India |
Ceyoka(Pvt)Ltd |
Accepted for review.(excisting product). |
MEC decision for the medicine applications received via e-NMRA system from 26.11.2020 to 24.01.2021.
| Reference No | Name of Product | Brand Name | Manufacturer Name | Importer | MEC decision |
|---|---|---|---|---|---|
| MEDREG/2020/00099 |
Diclofenac diethylamine Gel 1.16% w/w |
Subsyde GEL |
Raptakos, Brett and Co. Ltd, India |
Pharma Associates |
Rejected informing that this strength is not need and healthcare care need of the country can be fulfilled by the existing products in Sri Lanka |
| MEDREG/2020/00101 |
Permethrin Lotion BP 1% |
A Lices Lotion |
HOE Pharmaceutical SDN BHD, Maylasia |
Indoscan (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00163 |
Tacrolimus Capsules USP 1mg |
Vingraf 1 |
Emcure Pharmaceuticals Limited,India |
Emerchemie NB (Ceylon) Ltd |
Accepted for review |
| MEDREG/2020/00200 |
Ciclosporin Capsules USP 25mg |
PICOSPORIN 25 |
United Biotech (P) Limited,India |
Klintas Pvt Ltd |
Accepted for review |
| MEDREG/2020/00201 |
Febuxostat Tablet (film coated) 80mg |
FEBULIV 80 |
ATRA Pharmaceuticals Ltd,India |
Tabrane Healthcare (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00259 |
Montelukast Tablet BP 10mg |
Monocast 10 |
Beximco Pharmaceuticals Limited, Bangladesh |
Emerchemie NB (Ceylon) Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00273 |
Methylprednisolone Tablet IP 16 mg |
M NISOL 16 |
Steril gene Life Sciences P Ltd,India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00292 |
Diazepam Injection (solution) BP 5 mg / ml |
DIAPAM |
SAKAR HEALTHCARE LTD.India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00297 |
Azithromycin Tablet USP 500mg |
Zithrin 500 |
Renata Limited,Bangladesh |
Emerchemie NB (Ceylon) Ltd |
Accepted for review (excisting product) request Bio Equivalence data |
| MEDREG/2020/00316 |
Esomeprazole Capsule, delayed release USP 20 mg |
ANESO |
AMN Life Science Pvt Ltd,India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00317 |
Silver sulfadiazine Cream (topical) USP 1% w/w |
SILVIRIN |
Raptakos, Brett and Co. Ltd,India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00321 |
Esomeprazole Capsule, delayed release USP 40 mg |
ANESO 40 |
AMN Life Science Pvt Ltd,India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00328 |
Cefalexin Capsules BP 250 mg |
NISCEF 250 |
Kniss Laboratories Pvt Ltd,India |
Pharma Associates |
Rejected informing that the healthcare care need of the country can be fulfilled by the existing products in Sri Lanka |
| MEDREG/2020/00333 |
Dapagliflozin Tablet (film coated) 5mg |
DAP 5 |
BIOPHARMA LIMITED,Bangladesh |
TRUVIC PRIVATE LIMITED |
Accepted for review |
| MEDREG/2020/00340 |
Warfarin sodium Tablet (uncoated) USP 3 mg |
ZOFARIN 3 |
Cadila Healthcare Limited |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00361 |
Aciclovir Tablet (uncoated) BP 200mg |
Cyclovir Tablets |
Cadila Healthcare Limited,India |
Sunshine Healthcare Lanka Limited |
Accepted for review |
| MEDREG/2020/00367 |
Tamsulosin hydrochloride Prolonged-Release Capsules BP 0.4mg |
OD TAM 0.4 |
Aurobindo Pharma Limited,India |
Alaris Lanka (Private) Limited |
Accepted for review, request Bio Equivalence data |
| MEDREG/2020/00387 |
Tramadol Injection (solution) 50 mg / ml |
E DOL |
SAKAR HEALTHCARE LIMITED,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00389 |
Vancomycin Injection (powder, lyophilized, for solution) USP 500 mg |
VANKAR 500 |
SAKAR HEALTHCARE LIMITED,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00390 |
Isotretinoin Capsule, soft gelatin USP 20mg |
ACNETREX 20 |
MEGA LIFESCIENCES Public Company Limited.Thailand |
A. Baur and Co. (Pvt.) Ltd. |
Accepted for review |
| MEDREG/2020/00394 |
Fenofibrate Capsules USP 200 mg |
FIBRAL |
Micro Labs Limited,India |
Micro Mega Lanka (Pvt) Ltd. |
Accepted for review |
| MEDREG/2020/00403 |
Metoclopramide Tablet (uncoated) BP 10 mg |
Mercury Laboratories Limited,India |
Yaden International Private Limited |
Accepted for review |
|
| MEDREG/2020/00413 |
Cetirizine hydrochloride Oral Solution BP 5 mg/ 5 ml |
Cetzed |
G.D. Laboratories India Private Limited,India |
Lifeline Pharmaceuticals (Pvt) Limited |
Accepted for review |
| MEDREG/2020/00418 |
Amoxicillin500mgClavulanic acid125mg Tablet USP |
Theoclav 625 |
Theon Pharmaceuticals Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00419 |
Vancomycin Injection (powder, lyophilized, for solution) USP 500mg |
Vamocin |
Gufic Biosciences Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00089 |
Sildenafil Tablet 100mg |
MAXIGRA 100 |
Saga Life Sciences Limited,India |
Klintas Pvt Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00128 |
Hydroxyprogesterone Injection (solution) USP 250mg/ml |
FEMOLIFE |
Aburaihan Pharmaceutical Company, Iran |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00141 |
Levothyroxine sodium Tablet 25mcg |
EUTHYROX 25 |
Merck Serono GmbH, Germany |
Emerchemie NB (Ceylon) Ltd |
Accepted for review |
| MEDREG/2020/00226 |
Cetirizine Dihydrochloride Syrup 1mg/ml |
ARIX |
Tabros Pharma (Pvt) Ltd, Pakistan |
Associated Laboratories (Private) Limited |
Accepted for review |
| MEDREG/2020/00264 |
Prazosin Tablet BP 1mg |
Alphapress 1 |
Renata Limited ,Bangladesh |
Emerchemie NB (Ceylon) Ltd |
Accepted for review |
| MEDREG/2020/00304 |
Retinol2750 I.U.Colecalciferol (Vitamin D3)250 I.U.Vitamin E (Tocopherol)5 mgThiamine (Vitamin B1)1 mgRiboflavin (Vitamin B2)1 mgPyridoxine (Vitamin B6)1 mgDexpanthenol2.5 mgNicotinamide10 mgVitamin C (Ascorbic acid)40 mgZinc sulphate13.3 mg Oral drops |
HOVITE Z Drops |
Raptakos, Brett and Co. Ltd |
Pharma Associates |
Submit as Borderline product |
| MEDREG/2020/00325 |
Clarithromycin Tablet USP 500mg |
ACEM 500 |
Emcure Pharmaceuticals Limited, India. |
Emerchemie NB (Ceylon) Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00375 |
Terbinafine Tablet 250mg |
Onchofin 250 |
Aurobindo Pharma Limited,India |
Alaris Lanka (Private) Limited |
Accepted for review |
| MEDREG/2020/00411 |
Bisoprolol Tablet (film coated) USP 5mg |
Bisotrol 5 |
IPCA Laboratories Ltd,India |
Emar Pharma (Pvt) Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00412 |
Cefixime Tablet USP 200mg |
FIXITIL T |
Tabros Pharma pvt Ltd, Pakistan |
Associated Laboratories (Private) Limited |
Accepted for review, request Bio Equivalence data |
| MEDREG/2020/00425 |
Thiamine (Vitamin B1)100mgPyridoxine (Vitamin B6)200mgCyanocobalamin200mcg Tablet (film coated) USP |
SOLBION |
Eskayef Pharmaceuticals Limited, Bangladesh |
TRUVIC PRIVATE LIMITED |
Submit as Borderline product |
| MEDREG/2020/00431 |
Amoxicillin Capsules USP 500mg |
NUMOX 500 |
Saitech Medicare Pvt. Limited |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00433 |
Teicoplanin Injection (powder for solution) 400mg |
Ticplat 400 |
Gufic Biosciences Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00435 |
Salmeterol 25mcgFluticasone 50mcg Aerosol, metered |
Seretide Evohaler |
Glaxo Wellcome Production, France |
GlaxoSmithKline Pharmaceuticals (Private) Limited |
Accepted for review |
| MEDREG/2020/00443 |
Esomeprazole Tablet, enteric coated 20mg |
Esopel 20 |
Medopharm Private Limited |
Sunshine Healthcare Lanka Limited |
Accepted for review |
| MEDREG/2020/00452 |
Ciclosporin Capsule, soft gelatin USP 50mg |
PICOSPORIN 50 |
United Biotech Private Limited,India |
Klintas Pvt Ltd |
Accepted for review |
| MEDREG/2020/00460 |
Mupirocin Ointment USP 2% W/W |
B Bact |
Indi Pharma Private Limited,India |
Emar Pharma (Pvt) Ltd |
Rejected informing that the healthcare care need of the country can be full filled by the existing products in Sri Lanka |
| MEDREG/2020/00468 |
Ceftazidime Injectables USP 1 gm |
MANZID 1000 |
Maan pharmaceuticals limited ,India |
P.T.C MEDICAL (PVT) LTD |
Seek the opinion from Sri Lanka College of Microbiologists. |
| MEDREG/2020/00470 |
Famotidine Tablet USP 20 mg |
Labotine 20 |
Laborate Pharmaceuticals India Limited.India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00473 |
Metoprolol Extended-Release Tablets USP 25 mg |
Prolomet XL 25 |
Sun Pharmaceutical Industries Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00476 |
Olanzapine Tablet (film coated) USP 10 mg |
OLANDUS 10 |
Cadila Healthcare Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00479 |
Chlordiazepoxide hydrochloride Tablet USP 5mg |
Mercury Laboratories Limited,India |
Yaden International Private Limited |
Accepted for review |
|
| MEDREG/2020/00487 |
Methylphenidate hydrochloride Tablet USP 10mg |
Rubifen |
Laboratories Rubio SA,Spain. |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00501 |
Clopidogrel Tablet USP 75 mg |
CLOPIREL |
Belco Pharma,India |
Pharmatec Pvt Ltd |
Accepted for review |
| MEDREG/2020/00503 |
Colecalciferol (Vitamin D3) Oral drops 400 IU |
ARBIVIT 3 Drops |
Raptakos, Brett and Co. Ltd,India |
Pharma Associates |
Accepted for review |
| MEDREG/2020/00506 |
Tigecycline Injection (powder, lyophilized, for solution) USP 50 mg |
TYLIN |
Gufic Biosciences Ltd,India |
Slim Pharmaceuticals Pvt ltd |
Accepted for review |
| MEDREG/2020/00510 |
Hydrochlorothiazide Tablet BP 25 mg |
Mercury Laboratories Limited |
Yaden International Private Limited |
Accepted for review |
|
| MEDREG/2020/00519 |
Tolterodine Tablet (film coated) 2 mg |
ROLITEN 2 mg |
Sun Pharmaceuticals Industries Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00530 |
Omeprazole Injection (powder, lyophilized, for solution) 40 mg |
OMEKAR |
SAKAR HEALTHCARE LIMITED,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00544 |
Lidocaine Spray 10% (100 mg/1 g) - 10 mg/dose |
Xylocaine Pump Spray |
AstraZeneca AB, Switzerland |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00550 |
Promethazine Injection (solution) BP 25 mg / ml |
Ciron Drugs and Pharmaceuticals Pvt Ltd, India |
Ceyoka(Pvt)Ltd |
Accepted for review |
|
| MEDREG/2020/00552 |
Fluticasone Inhalant BP 50mcg/Dose |
Heilongjiang Province Fulekang Pharmaceutical Co., Ltd, China |
Ceyoka(Pvt)Ltd |
Accepted for review | |
| MEDREG/2020/00555 |
Beclometasone dipropionate Inhalant BP 50mcg/Dose |
Heilongjiang Province Fulekang Pharmaceutical Co., Ltd, China |
Ceyoka(Pvt)Ltd |
Accepted for review | |
| MEDREG/2020/00561 |
Topiramate Tablet (film coated) USP 50 mg |
TOPIRAM 50 |
Cadila Healthcare Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00576 |
Warfarin sodium Tablet (uncoated) USP 10 mg |
ZOFARIN 10 |
Cadila Healthcare Limited,India |
Hemas Pharmaceuticals Pvt Ltd |
Seek the opinion from Sri Lanka College of Haematologists |
| MEDREG/2020/00581 |
Regorafenib Tablet (film coated) 40 mg |
REGANEX 40 |
Julphar Bangladesh Ltd. Bangladesh |
Tabrane Healthcare (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00588 |
Mometasone furoate Nasal spray BP 50mcg |
Momesone |
Incepta Pharmaceuticals Ltd |
Citihealth Imports Private Limited |
Accepted for review |
| MEDREG/2020/00095 |
Piperacillin4gTozabactam0.5g Injection (powder for solution) USP |
PYBACTUM |
Astral Steritech Pvt. Ltd.India |
A. Baur and Co. (Pvt.) Ltd. |
Accepted for review |
| MEDREG/2020/00221 |
Tetracycline Ointment (topical) USP 3% W/W |
Galentic Pharma (India) Private Limited,India |
Ceyoka(Pvt)Ltd |
Accepted for review | |
| MEDREG/2020/00310 |
Povidone-iodine Ointment (topical) USP 5% W/W |
APODIN OINTMENT |
Globe Pharmaceuticals Ltd, Bangladesh |
Tabrane Healthcare (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00322 |
Ciprofloxacin Eye and Ear drops 0.3% w/v |
I CIP |
AXA PARENTERALS LTD,India |
ABC PHARMA SERVICES (PVT) LTD |
Accepted for review |
| MEDREG/2020/00358 |
Rosuvastatin Tablet USP 10 mg |
ROSCA |
Genix Pharma(Pvt)Ltd, Pakistan |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00376 |
Ferrous Ascorbate(Eq.to 30 mg of Elemental Iron) Folic acid550 mcg Oral Suspension |
Chelferry |
Leben Laboratories Pvt Ltd,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00388 |
Clotrimazole Vaginal tablet USP 500mg |
CANDID V1 |
Glenmark Pharmaceuticals Limited, India |
Sunshine Healthcare Lanka Limited |
Accepted for review |
| MEDREG/2020/00400 |
Cyproheptadine hydrochloride Tablet BP 4 mg |
CYPINE TABLET |
Leben Laboratories Pvt Ltd,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00404 |
Clomifene citrate Tablet BP 50mg |
Voi Tablet BP 50mg |
Genix Pharma (Pvt) Ltd, Pakistan |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00415 |
Docetaxel Injection (solution) USP 10 mg/ml |
ZYTAX 80 |
Zydus Hospira Oncology Pvt. Ltd, India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00437 |
Pethidine Injection (solution) BP 50MG/ML |
VERPAT 50 |
Verve Human Care Laboratories |
Leader Pharma Agency (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00126 |
Esomeprazole Injection (powder for solution for infusion) 40 mg |
NEXIUM |
AstraZeneca AB ,Switzerland |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00222 |
Goserelin Implant 10.8 mg |
Zoladex LA |
AstraZeneca UK Limited, UK |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00295 |
Bisacodyl Suppositories USP 10mg |
Conlax 10 |
Bliss GVS Pharma Ltd,India |
Sunshine Healthcare Lanka Limited |
Accepted for review |
| MEDREG/2020/00409 |
Levofloxacin Injection (solution for infusion) 500 mg/ 100 ml |
Leflox |
Getz Pharma (Pvt) Ltd, Pakistan |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00448 |
Carboxymethyl Cellulose Eye Drops 1% ( 10 mg/ml ) |
REFRESH LIQUIGEL |
Allergan Sales LLC,USA |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00464 |
Diclofenac diethylamine Gel BP 1% (W/W) |
ADIFLAM GEL |
Leben Laboratories Pvt Ltd,India |
Ceyoka(Pvt)Ltd |
Accepted for review |
| MEDREG/2020/00465 |
Salmeterol 50mcgFluticasone 500mcg Powder, metered |
Seretide Accuhaler Diskus |
Glaxo Wellcome Production, France |
GlaxoSmithKline Pharmaceuticals (Private) Limited |
Accepted for review |
| MEDREG/2020/00493 |
Amiodarone hydrochloride Injection (solution) 50mg/ml |
AMRONE |
Verve Human Care Laboratories |
Leader Pharma Agency (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00498 |
Atorvastatin Tablet (film coated) 20mg |
LIPIZIM 20 |
ZIM LABORATORIES LIMITED,India |
Tabrane Pharmaceuticals (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00521 |
Clobazam Tablet (uncoated) BP 10MG |
VERCLOB |
Verve Human Care Laboratories,India |
Leader Pharma Agency (Pvt) Ltd |
Accepted for review |
| MEDREG/2020/00525 |
Sodium Fusidate Tablet (film coated) 250 mg |
FUCIDIN TABLETS |
Laboratories Leo, France |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| MEDREG/2020/00559 |
Piracetam Tablet (film coated) 800 mg |
KALCETAM 800 mg |
PT Dankos Farma,India |
Hemas Pharmaceuticals Pvt Ltd |
Accepted for review |
| Reference no | Name of the product | Brand name | Manufacturer | Importer | MEC decision |
|---|---|---|---|---|---|
| MEDREG/2020/00062 | Betahistine Tablet BP 8mg | DIZIMARC 8mg | Healer's Lab, Unit II, India | Canoe Medicare (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00064 | Betahistine Tablet BP 16mg | DIZIMARC 16mg | Healer's Lab, Unit II, India | Canoe Medicare (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00145 | Metformin Tablet, prolonged release 1000 mg | Glucophage XR 1000 | Merck Sante, France | Emerchemie NB (Ceylon) Ltd | New strength. Accepted for review. Need to negotiate price |
| MEDREG/2020/00220 | Fluticasone 250mcgSalmeterol 25mcg Aerosol, metered | Seretide Evohaler | Glaxowellcome Production, France | GlaxoSmithKline Pharmaceuticals (Private) Limited | Accepted for review |
| MEDREG/2020/00248 | Ivabradine Tablet (film coated) 5 mg | IVAB 5 TABLETS | Bafna Pharmaceuticals Ltd, India | Pharma Associates | Accepted for review |
| MEDREG/2020/00275 | Fexofenadine hydrochloride Tablet (film coated) USP 120mg | ODIFEX 120 | Agio Pharmaceuticals Ltd, India | Citihealth Imports Private Limited | Accepted for review |
| MEDREG/2020/00308 | Methylprednisolone Tablet USP 4mg | MONOCORTIL M4 | Healer's Lab (Unit II), India | Canoe Medicare (Pvt) Ltd | Accepted for review. Need special focus on price |
| MEDREG/2020/00315 | Ursodeoxycholic acid Tablet USP 150mg | UDCOLIV 150 | Healers Lab, Unit II, India | Canoe Medicare (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00329 | Dapagliflozin Tablet 10mg | DAP 10 | BIOPHARMA LIMITED, Bangladesh | TRUVIC PRIVATE LIMITED | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00332 | Vecuronium bromide Injection (powder, lyophilized, for solution) BP 10 mg | SACURON 10 | SAKAR HEALTHCARE LIMITED, India | Ceyoka(Pvt)Ltd | to seek the opinion from the College of Anaesthesiologists |
| MEDREG/2020/00334 | Aciclovir Tablet (uncoated) BP 200 | Treffer Pharmaceuticals, India | Yaden International Private Limited | Accepted for review | |
| MEDREG/2020/00338 | Amitryptyline hydrochloride Tablet (film coated) BP 10 mg | Treffer Pharmaceuticals, India | Yaden International Private Limited | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. | |
| MEDREG/2020/00341 | Solifenacin Succinate Tablet (film coated) 10 mg | Solifen | Getz Pharma Pvt Limited, Pakistan | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00344 | Warfarin sodium Tablet (uncoated) USP 5 mg | ZOFARIN 5 | Cadila Healthcare Limited, India | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00346 | Acetazolamide Tablet (uncoated) BP 250 mg | Mercury Laboratories Limited, India | Yaden International Private Limited | Accepted for review | |
| MEDREG/2020/00347 | Sodium valproate Gastro-Resistant Tablets BP 200 mg | S VALAPRO 200 | AMN Life Science Pvt Ltd, India | Pharma Associates | Accepted for review |
| MEDREG/2020/00349 | Erythromycin Tablet (film coated) BP 500 mg | Mercury Laboratories Limited, India | Yaden International Private Limited | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. | |
| MEDREG/2020/00350 | Ropinirole Tablet (film coated) USP 0.5mg | Treffer Pharmaceuticals, India | Yaden International Private Limited | Accepted for review | |
| MEDREG/2020/00351 | Gliclazide Tablet, modified release 60mg | Glix MR 60 | Wallace Laboratories Private Limited, India | Emar Pharma (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00380 | Losartan potassium50mgHydrochlorothiazide12.5mg Tablet (film coated) USP | NORMOZIDE | CCL Pharmaceuticals Pvt Ltd, Pakistan | CIC Holdings PLC | Accepted for review |
| MEDREG/2020/00383 | Oxytocin Injection (solution) USP 5 Units in 1ml | MARITON | Chengdu Hepatunn Pharmaceutical Co.,Ltd, China | Slim Pharmaceuticals Pvt ltd | Accepted for review |
| MEDREG/2020/00385 | Clarithromycin Tablet (film coated) USP 250mg | Neo Klar | CCL Pharmaceuticals Pvt Ltd, Pakistan | CIC Holdings PLC | Accepted for review |
| MEDREG/2020/00392 | Telmisartan Tablet USP 40mg | T SAR | CCL Pharmaceuticals Pvt Ltd, Pakistan | CIC Holdings PLC | Accepted for review |
| MEDREG/2020/00395 | Telmisartan Tablet USP 80mg | T SAR | CCL Pharmaceuticals Pvt Ltd, Pakistan | CIC Holdings PLC | Accepted for review |
| MEDREG/2020/00426 | Atorvastatin Tablet 10 mg | Vast 10 | Lincoln Pharmaceuticals ltd,India | Pharmatec Pvt Ltd | Existing product- new no due to late submission |
| MEDREG/2020/00102 | Tamoxifen Tablet (film coated) BP 20mg | Nolvadex D | AstraZeneca UK Limited, UK | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00114 | Fusidic acid Cream (topical) BP 2% w/w | Fusil Cream | Tabros Pharma (Pvt) Ltd, Pakistan | Associated Laboratories (Private) Limited | Accepted for review |
| MEDREG/2020/00121 | Povidone-iodine Solution, topical USP 0.75% w/v | Pyodine Surgical Scrub | Brookes Pharma (Private) Limited, Pakistan | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00252 | Mometasone furoate Ointment USP 0.1% w/w | Momate Ointment | Glenmark Pharmaceuticals Limited, India | Sunshine Healthcare Lanka Limited | Accepted for review |
| MEDREG/2020/00359 | Montelukast Chewable Tablets 4 mg | Montiget | Getz Pharma Pvt Limited,India | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00363 | Retinol4000 I.U.Colecalciferol (Vitamin D3)400 I.U.Vitamin E (Tocopherol)5 mgThiamine (Vitamin B1)3 mgRiboflavin (Vitamin B2)1.2 mgPyridoxine (Vitamin B6)1 mgDexpanthenol5 mgNicotinamide25 mgVitamin C (Ascorbic acid)50 mgCyanocobalamin3 mcg Syrup | Hovite Syrup | Raptakos, Brett and Co. Ltd, India | Pharma Associates | To submit borderline product |
| MEDREG/2020/00366 | Sitagliptin Tablet (film coated) USP 50 mg | SITAGLIP 50 | The ACME Laboratories Ltd.Bangladesh | Mega Pharma (Pvt) Ltd. | Accepted for review |
| MEDREG/2020/00381 | Tobramycin0.3% w/vDexamethasone0.1% w/v Ear drops | DEXATOB | AXA PARENTERALS LTD, India | ABC PHARMA SERVICES (PVT) LTD | Accepted for review |
| MEDREG/2020/00109 | Iopromide Injection (solution) 768.86mg (equal to 370mg of Iodine) 370 mgI/1ml | Ultravist 370 | Bayer AG, Germany | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00115 | Sildenafil Tablet 50mg | Trufil | Astron Limited, Sri Lanka | Astron Limited | Accepted for review |
| MEDREG/2020/00117 | Amoxicillin500mgClavulanic acid125mg Tablet (film coated) BP | MOXICLAV 625mg | Medochemie Ltd (Factory B), Cyprus | Associated Laboratories (Private) Limited | Accepted for review |
| MEDREG/2020/00127 | Mesalazine Prolonged-Release Tablets 500mg | PENTASA | Ferring International Center SA, Switzerland | Sunshine Healthcare Lanka Ltd | Accepted for review |
| MEDREG/2020/00138 | Sulfamethoxazole400mgTrimethoprim80mg Tablet (uncoated) BP | MEGATRIM | Fourrts (India) Laboratories Pvt. Limited, India | Sunshine Healthcare Lanka Limited | Accepted for review |
| MEDREG/2020/00151 | Atorvastatin Tablet (film coated) 10mg | LIPLO 10 | Globe Pharmaceuticals Ltd, Bangladesh | Tabrane Healthcare (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00152 | Atorvastatin Tablet (film coated) 20 mg | LIPLO 20 | Globe Pharmaceuticals Ltd, Bangladesh | Tabrane Healthcare (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00179 | Salmeterol Aerosol, metered 25 mcg /Actuation | Combiwave SF 125 | Glenmark Pharmaceuticals Ltd. India | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| MEDREG/2020/00199 | Mannitol Intravenous Infusion BP 20% w/v | N/A | Sichuan Kelun Pharmaceutical Co., Ltd, China | Pharma Associates | Accepted for review |
| MEDREG/2020/00262 | Methylphenidate hydrochloride Tablet 10 | Ritalin | Novartis Farmaceutica SA, Spain | A. Baur and Co. (Pvt.) Ltd. | Accepted for review |
| MEDREG/2020/00360 | Montelukast Chewable Tablets 5 mg | Montiget | Getz Pharma Pvt Limited,Pakistan | Hemas Pharmaceuticals Pvt Ltd | Accepted for review |
| Medicine applications received via e-NMRA system from 22.09.2020 to 27.10.2020. | |||||
| Reference No | Name of the Product | Brand Name | Manufacturer Name | Importer | MEC Discussion |
|---|---|---|---|---|---|
| MEDREG/2020/00112 | Amoxicillin Capsule USP 250mg | NUMOX 250 | Saitech Medicare Pvt.Limited,India | Slim Pharmaceuticals (Pvt) Ltd | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00192 | Fat emulsion20%Amino Acids17 AAGlucose11% Injection (emulsion for infusion) | N/A | Sichuan Kelun Pharmaceutical Co., Ltd,China | Ashani Koralage 116, Layards Broadway, Colombo-14 | Accepted for review |
| MEDREG/2020/00216 | Azithromycin Oral Suspension USP 200mg/5ml | ZIMYCIN DRY SYRUP | Saga Lifesciences Limited,India | Klintas (Pvt) Ltd, | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00234 | Dapagliflozin Tablet 10mg | Dflozin 10mg | Hilton Pharma (Pvt) Ltd,Pakistan | Sunshine Healthcare Ltd, | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00245 | Febuxostat Tablet (film coated) 40mg | FEBULIV 40 | Atra Pharmaceuticals Limited,India | Tabrane Healthcare (Pvt) Ltd | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00249 | Calcitriol Capsule BP 0.25 mcg | Softgel Healthcare Pvt Ltd,India | Pharma Associate | Accepted for review | |
| MEDREG/2020/00258 | Clobazam Tablet BP 10 mg | Clobas 10 | The Madras Pharmaceuticals,India | Pharma Associate | Accepted for review |
| MEDREG/2020/00272 | Atropine sulphate Injection (solution) BP 0.6 mg / ml | Ciron Drugs and Pharmaceuticals Pvt Ltd,India | Ceyoka(Pvt)Ltd, | Accepted for review | |
| MEDREG/2020/00277 | Amoxicillin Capsules BP 250 mg | RANOXYL 250 | Sun Pharmaceutical Industries Ltd.India | Hemas Pharmaceuticalas | Accepted for review if Bio equivalence/Bio Waiver data provided. -Existing product |
| MEDREG/2020/00284 | Febuxostat Tablet (film coated) 40 mg | Febo G | Getz Pharma (Pvt.) Limited,India | Hemas Pharmaceuticalas | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00330 | Solifenacin Succinate Tablet (film coated) 5 mg | Solifen | Getz Pharma Pvt Limited,India | Hemas Pharmaceuticalas | Accepted for review |
| MEDREG/2020/00335 | Cefalexin Capsules BP 500 mg | NISCEF 500 | Kniss Laboratories Pvt Ltd,India | Ashani Koralage 116, Layards Broadway, Colombo-14 | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00342 | Tranexamic acid Injection BP 100 mg in 1 ml | MELIOXAMIC | Mercury Laboratories Limited, India | Yaden Internatinal Ltd | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00352 | Ofloxacin Tablet (film coated) USP 200 mg | Treffer Pharmaceuticals,India | Yaden Internatinal Ltd | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. | |
| Medicine applications received via e-NMRA system from 25.07.2020 to 25.08.2020 |
|||||
| Reference no | Name of the product | Brand name | Manufacturer | Importer | MEC Decision |
|---|---|---|---|---|---|
| MEDREG/2019/00028 | Atorvastatin Tablet 20mg | ATOVIC 20 | Astron Limited,Sri Lanka | Accepted for review as this is local manufacturer. | |
| MEDREG/2019/00047 | Cefixime Tablets 100mg | ECOCEF 100 | Indchemie Health Specialities (Pvt) Ltd, India | Pharma Associate | Rejected as this strength is not needed to the country and informed to phase out all the existing cefixime tablets 100mg giving reasonable time period to the MAHs |
| MEDREG/2019/00048 | Paracetamol Injection (concentrate solution for infusion) 10mg/ml | PARAFUSIV | S.M. Farmaceutici SRL, Italy | Emerchemie NB (Ceylon) Limited | Accepted for review |
| MEDREG/2019/00060 | Phenytoin Injections 250mg/5ml | EPITOIN | VEM Ilaç San. Ve Tic.A.S.,Turkey | Pharma Associates | Accepted for review |
| MEDREG/2019/00088 | Fat emulsion20% Amino Acids17 AA,Glucose11% Injection (emulsion for infusion) | N/A | Sichuan Kelun Pharmaceutical Co.Ltd,China | Pharma Associates | Accepted for review |
| MEDREG/2019/000107 | Metaraminol Injection (solution for infusion) BP 10mg/ml | TorbayPharmaeutical, UK | The Esses pharmacy (Pvt.) Ltd. | Accepted for review | |
| MEDREG/2019/000153 | Pregabalin Capsules 50mg | PREGASAFE 50 | MSN Laboratories Private Limited,India | Axia Private Limited | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products |
| MEDREG/2019/000162 | Clotrimazole Cream (topical) BP 1% w/w | CALCREM | Raptakos, Brett and Co. Ltd,India | Pharma Associates | Rejected informing that the healthcare need of the country can be fulfilled by the existing products |
| MEDREG/2019/000184 | Empagliflozin Tablet (film coated) 25mg | SUCOZIN 25 | Globe Pharmaceuticals Ltd, Bangladesh | Tabrane Healthcare (Pvt) Ltd | Accepted for review and informed to make special focus on the price |
| MEDREG/2019/00050 | Torasemide Tablet 10 mg | DYTOR | Cipla Ltd ,India | Breathe Free Lanka (Private) Limited | Accepted for priority review as only furosemide is available from this group. |
| Reference no | Name of the product | Brand name | Manufacturer | Importer | MEC Decision |
|---|---|---|---|---|---|
| MEDREG/2020/00083 | Sitagliptin Tablet (film coated) BP 50 mg | SITAGMOR 50 | Morison PLC,Sri Lanka | Accepted for review as this is local manufacturer. | |
| MEDREG/2020/00124 | Methylprednisolone Acetate Injection (suspension) BP 40 mg | DEPO PRED 40 | Ziska Pharmaceuticals Limited, Bangladesh | Tabrane Pharmaceuticals (Pvt) Ltd | Accepted for review |
| MEDREG/2020/00140 | Levothyroxine sodium Tablet 100mcg | EUTHYROX 100 | Merck Serono GmbH, Germany | Emerchemie NB (Ceylon) Ltd | Accepted for review via the reliance path |
| MEDREG/2020/00148 | Cefuroxime axetil Powder, for oral suspension USP 125mg/5ml | OZAX DRY SYRUP | Saga Life sciences Limited, India | Klintas Pvt Ltd | Accepted for review |
| MEDREG/2020/00150 | Levothyroxine sodium Tablet 50mcg | EUTHYROX 50 | Merck Serono GmbH, Germany | Emerchemie NB (Ceylon) Ltd | Accepted for review via the reliance path |
| MEDREG/2020/00173 | Topiramate Tablet USP 25 mg | Neurotop 25 | The Madras Pharmaceuticals, India | Pharma Associates | Accepted for review |
| MEDREG/2020/00182 | Azithromycin Tablet 500mg | ZIMYCIN 500 | Saga Lifesciences Limited, India | Klintas Pvt Ltd | Rejected by informing that the healthcare need of the country can be fulfilled by the existing products. |
| MEDREG/2020/00191 | Nicorandil Tablet BP 10mg | NICORLIN | Lina Manufacturing (Pvt) Ltd, Sri Lanka | - | Accepted for review as this is local manufacturer. |
| MEDREG/2020/00227 | Paracetamol Tablet BP 500mg | RAPISOL | Astron Limited, Sri Lanka | - | Accepted for review as this is local manufacturer. |
| MEDREG/2020/00232 | Methylprednisolone Tablet IP 8 mg | MNISOL 8 | Steril gene Life Sciences Pvt Ltd, India | Pharma Associates | Accepted for review |