As per the latest US FDA list, 14 Indian companies received 77 approvals or tentative approvals for active ingredients during January-November 2006 as compared to 60 approvals by 9 companies in the year 2005. Out of 77 US FDA approvals for active ingredients, 31 were tentative approvals and remaining 46 were final approvals. The Indian companies are well set to obtain more approvals in the coming years. Out of the US FDA approval list, Pharmabiz has taken approval for only one active ingredient and has not considered approval for different categories of same active ingredients.
Further, Indian companies received final approval for 57 ANDAs during January -November 2006 as compared to 50 ANDAs approvals in the previous year. Dr Reddy's Laboratories received approvals for 11 ANDAs in the latest period. This was followed by Orchid Healthcare 7 ANDAs, Aurobindo 6 ANDAs and Ranbaxy Laboratories, Caraco and Lupin received approvals for 5 ANDAs each. Several companies filed ANDAs and still large ANDAs are waiting for US FDA approval. During the period Jan-Nov 2006, 13 companies received approval for 57 ANDAs as against 50 ANDAs approved during previous year for 9 companies. Dabur Oncology Plc received approval for its Carboplatin ANDA during 2006 and Torrent Pharma for Quinapril Hydrochloride. Similarly, Glenmark Pharmaceuticals and Sun Pharmaceuticals received approvals for four ANDAs each as against nil in the previous year.
During the first eleven months of 2006, 14 Indian companies and their subsidiaries namely, Aurobindo Pharma, Sun Pharmaceuticals, Caraco Pharma (subsidiary of Sun Pharma), Cipla Ltd, Dabur Oncology Plc., Dr Reddy's Laboratories, Glenmark Pharma, Jubilant Pharma, Lupin, Orchid Healthcare, Ranbaxy Laboratories, Strides Acrolab, Wockhardt Ltd and Zydus Pharma, USA received 77 approvals/Tentative approvals from US FDA.
Aurobindo received highest numbers of US FDA approvals for 12 active ingredients as compared to 11 in the last year. Followed by Dr Reddy's Laboratories 11 approvals (8 in the previous year), Sun Pharmaceuticals & its US based subsidiary Caraco Pharma received total approvals for 13 products (5 approvals in last year). Zydus Pharma USA received 8 approvals (7 approvals) and Cipla Ltd received 7 approvals (Nil).
Ranbaxy Laboratories, among the top 10 global generic player, received approval for 17 active ingredients during 2005 and 6 ingredients in first eleven months of 2006. The company received approvals for Loperamide Hydrochlori, Simvastatin, Cefprozil and Doxycycline during 2006. It also received tentative approval for Cetrizine Hydrochlori and Risperidone in 2006.
Ranbaxy received US FDA approval for 5 ANDAs during 2006 and 12 ANDAs in the last year. Its ANDA filings with the US FDA are progressing as per its plan, with 9 ANDAs having been filed in the quarter ended September 2006. Its cumulative ANDAs reached at 178, with 62 ANDAs pending approval.
Aurobindo Pharma received firm approval for active ingredients like Citalopram Hydrobromid, Hydrochlor Othiazide, Meloxicam, Zidovudine, Mirtazapine, Cefuroxime Axetil Lisinopril and Lamivudine and Zidovudine during the first 11 months of 2006. The company also received tentative approval for Stavudine, Abacavir Sulfate, Simvastatin and Didanosine from US FDA. Similarly, Dr Reddy's Labs received seven final approval for Zonismide, Finasteride, Fexofenadine Hydrochlori, Ibuprofen; Pseudoephed, Meloxicam Pravastatin Sodium and Metformin Hydrochlorid. Further it received four tentative approvals for Rivastigmine Tartrate, Amlodipine Besylate, Amlodipine, and Maleate.
Zydus Group stepped up its filings in USA and received three approvals for Zonisamide, Warfarin and Meloxicam. It received tentative approvals for Pravastatin sodium, Levofloxacin, Carvedilol, Sertraline HCI, and Simvastatin during 2006. The company received 7 approvals or tentative approvals during 2005. The group filed 2 m more ANDAs and 5 additional DMFs during the second quarter ended September 2006 taking the total to 41 ANDAs filings and 45 DMFs. Its cumulative approvals reached at 17 and the company launched 7 products till September 2006. The company is now set to launch its products in Japan.
Strides Arcolab filed 10 ANDAs/NDA's with the US FDA during the third quarter ended September 2006 and its total filings reached at 21. The company received two ANDA approvals for Stavudine and Nevirapine under the expedited review provisions of the President's Emergency Plan for Aids relief program from the US FDA.
Glenmark Pharmaceuticals received four approvals for Meloxicam, Fluconazole, Gabapentin and Zonisamide during the January-November 2006 as against nil in the previous year. The company is also engaged in cutting-edge research in discovering new molecules and runs discovery project in the areas of inflammation and metabolic disorders.
The US FDA approved 4 active ingredients i.e. Ceftriaxone Sodium, Quinapril Hydrochlori, Cefdinir and Meloxicam of Lupin Ltd. During 2005 Lupin received approval for Cephalexin, Lisinopril and Cofprozil. The company filed three ANDAs and two DMFs during the quarter ended September 2006 and its total reached at seven ANDAs and Four DMFs.
Thus, the Indian companies are well set to launch new products in the world's largest and profitable US market in the coming years. The R&D expenditure of 34 major pharmaceutical companies during 2005-06 increased to Rs 1887crore from Rs 1529 crore in the previous year, a growth of 23.4 per cent. Further, Indian companies are investing in expansion and upgradation programme, which will enrich their product pipeline in coming years. However, considering the size of the Indian Pharmaceutical segment and number of players, very few players have managed to enter leading market like US.
View Table Information
View Table Information