Subject: Consolidated list of all cases of price fixation of new drugs received from various companies under para 5 of DPCO 2013 Sl. No. F.No. Name of the Company/ Formulation Date of receipt of application 1. 553 M/s Pure and Cure Healthcare Pvt. Ltd. and marketed by M/s Jenburkt Pharmaceuticals Ltd. Nervijen D3 tablet Each coated tablet contains: Alpha Liopic Acid 200mg Vitamin D3 1000 IU Pyridoxine HCl 3mg Mecobalamin 1500mcg Folic Acid 1.5mg Biotin 200mcg 2. 692 Marketed by M/s Magnet Labs Pvt. Ltd. and Manufactured by M/s Mankind Pharma Ltd. Omegaful Capsule (Omega-3- Acid Ethyl Esters, Mecobalamin, Vitamins and Minerals) Each soft gelatine Capsule contains: Omega-3 Acid Ethyl Esters 60 BP providing Elcosapentaenoic Acid 90mg, Docosahexaenoic Acid- 60mg, Mecobalamine- 500mcg, Pyridoxine Hydrochloride IP 3mg, Folic Acid- 1.5mg, Vitamin-E- 25IU, Vitamin- C- 100mg, and Zinc Sulphate IP eq. to Elemental Zinc 15mg sodium selenite pentahydrate BP eq. to Elemental Selenium 60mcg Status 18.7.2016 Pharmacoeconomics case, 03.5.2016 Pharmacoeconomics case, 3. 707 Manufactured & Marketed by M/s Ajanta Pharma Ltd. Each ml contains: Brinzolamide IP 1.0 w/v Timolol Maleate IP eq. to Timolol 0.5% w/v, Benzalkonium Chloride IP 0.01% w/v (as preservative) 4. 741 Manufactured And Marketed by M/s Albert David Limited Sioneuron F Tablet Thiamine Mononitrate IP 10mg, Pyridoxine Hydrochloride IP 3mg, Cyanocobalamin IP 15mcg, Nicotinamide IP 100mg, Calcium Pantothenate IP 50mg, Riboflavin IP 10mg, Vitamin C IP 150mg, Folic Acid IP 1500mcg 05.5.2016 Pharmacoeconomics case, 06.6.2016 Pharmacoeconomics case, 5. 786 Manufactured and Marketed by M/s Panacea Biotech Ltd. Each ml contains: Diphtheria Toxoid 20Lf (30 IU), Tetanus Toxoid 7.5Lf (60 IU), Inactivated w-b. pertussis bulk 10 IOU (4 IU), Hib (PRP- TT) (Hib PRP Conjugated with carrier protein Tetanus Toxoid) 10 ug, Aluminium content (A13+)(as Aluminium Phosphate Gel) 0.25mg, Thiomersal 0.025mg, 22.7.2016 Pharmacoeconomics case, 6. 881 Manufactured and marketed by M/s Zydus Healthcare Limited Alpha Lipoic Acid USP 100mg, Mecobalamin IP 1500mcg, Pyridoxine Hydrochloride IP 3mg, Vtamin D3 (As Stabilized) 1000IU, Folic Acid IP 1.5mg 13.12.2016 Pharmacoeconomics case, 7. 896 Manufactured by M/s GKM New Pharma and Marketed by M/s Atorvastatin Calcium IP eq. to Atorvastatin 5mg (As granules) 8. 897 Manufactured by M/s GKM New Pharma and Marketed by M/s Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As granules) 9. 898 Manufactured by M/s GKM New Pharma and Marketed by M/s Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As granules)
10. 956 Manufactured And Marketed by M/s Aristo Pharmaceuticals Pvt. Ltd. Atorvastatin Calcium eq. to Atorvastatin 10mg (as two filmcoated tablets of 5mg each), Aspirin 150mg (as two enteric coated tablets of 75mg each) 11. 1013 Manufactured by M/s Mylan Laboratories Limited and Marketed by M/s Mylan Pharmaceutical Pvt. Ltd. AVONZA Tablet Each tablet contains: Tenofovir Disoproxil Fumarate 300mg, Lamividine 300mg, Efavirenz 400mg 09.5.2017 Reffered to DCGI 27.7.2017 Pharmacoeconomics case, 12. 1074 Manufactured and marketed by M/s Sun Pharmaceuticals Industries Pvt. Ltd. Volini Maxx Gel 20GM contains: Diclofenac Diethylamine BP 2.32%w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salicylate IP 10% w/w Menthol IP 13. 1075 Manufactured and marketed by M/s Sun Pharmaceuticals Industries Pvt. Ltd. Volini Maxx Gel 30GM contains: Diclofenac Diethylamine BP 2.32%w/w (eq. to Diclofenac Sodium 2% w/w), Methyl Salicylate IP 10% w/w Menthol IP 14. 1080 Manufactured by M/s Synokem Pharmaceuticals Ltd. and Marketed by M/s Eris Lifesciences Limited Atorvastatin Calcium IP eq. to Atorvastatin 10mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg, Aspirin IP 75mg. 15. 1081 Manufactured by M/s Synokem Pharmaceuticals Ltd. and Marketed by M/s Eris Lifesciences Limited Atorvastatin Calcium IP eq. to Atorvastatin 20mg, Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg, Aspirin IP 75mg. 16. 1099 Manufactured & marketed by M/Sun Pharmaceuticals Volini Maxx Spray 15mg, contains: 17. 1100 Manufactured & marketed by M/Sun Pharmaceuticals Volini Maxx Spray 30mg, contains: 18. 1101 Manufactured & marketed by M/Sun Pharmaceuticals Volini Maxx Spray 40mg contains: 19. 1102 Manufactured & marketed by M/Sun Pharmaceuticals Volini Maxx Spray 60mg contains: 20. 1128 Manufactured by M/s GKM New Pharma. and Marketed by M/s 20 Tablet Olmesartan Medoxomil 20mg, Chlorthalidone IP 6.25mg, 21. 1129 Manufactured by M/s GKM New Pharma. and Marketed by M/s 20 HS Tablet Olmesartan Medoxomil 20mg, Chlorthalidone IP 12.5mg, 22. 1130 Manufactured by M/s GKM New Pharma. and Marketed by M/s 40 Tablet Olmesartan Medoxomil 40mg, Chlorthalidone IP 6.5mg, 06.10.2017 Pharmacoeconomics case, 06.10.2017 Pharmacoeconomics case, 01.11.2017 Reffered to DCGI 01.11.2017 Reffered to DCGI
23. 1131 Manufactured by M/s GKM New Pharma. and Marketed by M/s Unichem Laboratories Limited TRIOLSAR 40 HS Tablet Olmesartan Medoxomil 40mg, Chlorthalidone IP 12.5mg, 24. 1132 Manufactured by M/s GKM New Pharma. and Marketed by M/s Unichem Laboratories Limited TRILOSAR 6.25 Tablets Losartan Potassium IP 50mg, Chlorthalidone IP 6.25mg, 25. 1133 Manufactured by M/s GKM New Pharma. and Marketed by M/s Unichem Laboratories Limited TRILOSAR 12.5 Tablets Losartan Potassium IP 50mg, Chlorthalidone IP 12.5mg, 26. 1134 Manufactured by M/s GKM New Pharma. and Marketed by M/s 40 Tablet Chlorthalidone IP 6.25mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Telmisartan IP 40mg tablets 27. 1135 Manufactured by M/s GKM New Pharma. and Marketed by M/s 40 HS Tablet Chlorthalidone IP 12.5mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Telmisartan IP 40mg tablets 28. 1136 Manufactured by M/s GKM New Pharma. and Marketed by M/s 80 Tablet Chlorthalidone IP 6.25mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Telmisartan IP 80mg tablets 29. 1137 Manufactured by M/s GKM New Pharma. and Marketed by M/s 80 HS Tablet Chlorthalidone IP 12.5mg, Amlodipine Besylate IP eq. to Amlodipine 5mg, Telmisartan IP 80mg tablets 30. 1139 Manufactured and Marketed by M/s Apex Laboratories Pvt. Ltd. Sodium Fusidate IP eq. to Fusudic Acid 2%w/w, Halobetasol Propionate USP 0.05%w/w 31. 1146 Manufactured by M/s Mylan Laboratories Pvt. Ltd. and Marketed by M/s Mylan Pharmaceuticals Pvt. Ltd. HEPBEST Tablet Tenofovir Alafenamide Fumarate 25mg Tablet 01.12.2017 Pharmacoeconomics case, 07.12.2017 Pharmacoeconomics case, 32. 1147 Manufactured by M/s Uttaranchal Biotech Ltd. and Marketed by M/s Neon Laboratories Ltd. LOXHEAL Cream Nifedipine IP 0.3 percent weight by weight and Lidocaine IP 1.5 percent weight by weight Imidurea IP as Preservative 0.2percent weight by weight in Cream base 21.12.2017 Case is under examination for 33. 1150 Manufactured & Marketed By M/s Emcure Pharmaceuticals Limited Darunavir Ethanolate eq. to Darunavir 600mg and Ritonavir IP 100mg tablet 27.12.2017 Pharmacoeconomics case, 34. 1151 Manufactured by M/s Vapicare Pharma Pvt. Ltd. & Marketed By M/s Alembic Pharmaceuticals Limited Valembic 80 AM Tablets Amlodipine Besylate eq. to Amlodipine USP 5mg, Valsartan USP 80mg Tablet 35. 1152 Manufactured by M/s M/s Mascot Health Seris Pvt. Ltd. & Marketed By M/s Alembic Pharmaceuticals Limited GLZ Total Tablets Pioglitazone HCL IP eq. to Pioglitazone 15mg & Gliclazide IP 60mg (In modified release form) and Metformin HCL 500mg (extended release form)
36. 1154 Manufactured by M/s Vapicare Pharma Pvt. Ltd. & Marketed By M/s Alembic Pharmaceuticals Limited Valembic 160 AM Tablets Amlodipine Besylate eq. to Amlodipine USP 5mg, Valsartan USP 160mg Tablet 37. 1155 Manufactured by M/s Mylan Laboratories Pvt. Ltd. and Marketed by M/s Mylan Pharmaceuticals Pvt. Ltd. Nabtoxol Injection Paclitaxel (Protein Bound Particles) 100mg Injection 38. 1156 Manufactured by M/s Innova Captab Pvt. Ltd. and Marketed by M/s Abbott Healthcare Pvt. Ltd. Brufen Plus Ibuprofen IP 400mg & Paracetamol IP 325mg 39. 1159 Manufactured by M/s Akums Drugs & Pharmaceuticals Ltd. and Marketed by M/s Mankind Pharma Limited Each uncoated bilayered tablet contains: Telmisartan IP 40mg, Chlorthalidone IP 6.25mg 03.01.2018 Case is under examination for 03.01.2018 Case is under examination for 06.12.2017 Case is under examination for 40. 1160 Manufactured by M/s Cadila Healthcare Limited and Marketed by M/s Emcure Pharmaceuticals Ltd. Each Each Lyophilized vial contains: Trastuzumab 150mg Injection 41. 1161 Manufactured bym/s Zim Laboratories Limited and Marketed by M/s USV Limited D-RISE SURE Each orally Disintegrating Strip contains: Vitamin D3 (Cholecalciferol) IP 60000 IU Orally Disintegrating Strip 08.01.2017 Case is under examination for 08.01.2017 Case is under examination for 42. 1162 Manufactured bym/s Windlas Biotech Limited and marketed by M/s Alembic Pharmaceuticals Ltd. TRIVOGO 2/0.3 Mg Tablet Each uncoated bilayered tablet contains: Glimepiride IP 2mg, Metformin Hydrochloride IP 500mg (as SR form) Voglibose IP 0.3mg 43. 1168 Manufactured by M/s Ravenbhel Healthcare Pvt. Ltd. and marketed by M/s Abbott Healthcare Pvt. Ltd. Etoricoxib IP 60mg, Paracetamol IP 325mg 44. 1179 Manufactured by M/s Windlas Biotech Limited and marketed by M/s Abbott India Limited Each uncoated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 500mg (SR) 45. 1180 Manufactured by M/s Windlas Biotech Limited and marketed by M/s Abbott India Limited Each uncoated bilayered tablet contains: Teneligliptin Hydrobromide Hydrate eq. to Teneligliptin 20mg Metformin HCl 1000mg (SR) 46. 1170 Manufactured by M/s Synokem Pharmaceuticals Limited and marketed bym/s Bharat Serums and Vaccines Limited Misoprostol 600mcg Each uncoated tablet contains: Misoprostol IP 600mcg (As 1% Misoprostol dispersion) 12.01.2018 Case is under examination for 18.01.2018 Case is under examination for 19.01.2018 Case is under examination for 19.01.2018 Case is under examination for 22.01.2018 Case is under examination for 47. 1171 Manufacturer by M/s Hetero Labs Ltd. and marketed by M/s Torrent Pharmaceuticals Ltd. VELPACRUZ S Tablet Sofosbuvir IH 400mg, Velpatasvir IH 100mg 48. 1172 Manufacturer by M/s Synokem Pharmaceuticals Ltd.. and marketed by M/s M/s Emcure Pharmaceuticals Limited Atorvastatin Calcium IP eq. to Atorvastatin 10mg (As Pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets) 25.01.2018 Case is under examination for 49. 1173 Manufacturer by M/s Synokem Pharmaceuticals Ltd.. and marketed by M/s M/s Emcure Pharmaceuticals Limited Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As Pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As Pellets)
50. 1174 Manufactured by M/s Synokem Pharmaceuticals Ltd.. and marketed by M/s M/s Intas Pharmaceuticals Limited Rosuvastatin Calcium IP eq. to Rosuvastation 20mg (As pellets) Aspirin IP 75mg (As enteric coated pellets) Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As pellets) 51. 1175 Manufactured by M/s Windlas Biotech Ltd.. and marketed by M/s Intas Pharmaceuticals Limited Each uncoated bilayered tablet contains: Glimepiride IP 3mg, Metformin Hydrochloride IP 850mg (in Sustained release form) 52. 1176 Melphalan Injection IP 50mg Each vial contains: Melphalan HCL IP eq. to Melphalan 50mg, Povidone IP 20mg and Diluent For Melphalan Injection 10ml each vial contains Sodium Citrate IP 0.2g Proylene Glycol IP 6ml Ethanol (96%) IP 0.52ml water for Injection 53. 1177 Manufactured by M/s Innova Captab Pvt. Ltd.. and marketed by M/s Intas Pharmaceuticals Limited Each 5ml of suspension contains: Ferrous Ascorbate eq. to elemental Iron 30mg, Folic Acid IP 550mcg In a flavoured Syrupy base. 54. 1178 Manufactured and marketed by M/s Intas Pharmaceuticals Limited Each vial contains: Bortezomib IP 3.5mg Injection 31.01.2018 Case is under examination for 02.02.2018 Case is under examination for