The research based Indian pharmaceutical companies, including subsidiaries, have obtained 142 final ANDAs approvals and 49 tentative approvals from the US FDA during the year 2010 as against 132 and 34 respectively during last year. The Indian companies could grab almost 34 per cent of total final approvals during 2010 despite stringent approval system of US FDA. Investment in Research and Development has thus paid rich dividends to Indian companies and helped them to established strong presence in the international markets.
The US FDA's total number of final approvals reached at 418 ANDAs in 2010 as against 419 ANDAs in the preceding year and tentative approvals worked out to 121 ANDAs as compared to 124 ANDAs in the last year. Between 2007 and 2010, US FDA approved 1812 ANDAs and offered 401 tentative approvals to pharmaceutical companies worldwide. Aurobindo Pharma's final approval during last four years reached at 85 ANDAs and that of Sun Pharmaceutical at 79 ANDAs (including approvals received to its US based subsidiary Caraco Pharma). Dr Reddy's Laboratories has obtained 54 approvals and Glenmark received 50 final approvals.
Glenmark Pharmaceutical and its subsidiaries received highest number of final approval which reached at 20 ANDAs during 2010 and was followed by Aurobindo Pharma 17, Sun Pharmaceutical and Lupin 12 each, Dr Reddy's Laboratories 11, and Matrix Laboratories, subsidiary of Mylan Inc, 10 approvals. Strides Arcolab and its subsidiaries got 9 final approval and Zydus Pharma 8 in 2010.
Lupin's R&D expenditure increased sharply by 54.3 per cent during the year 2009-10 to Rs.412 crore from Rs.267 crore in the previous year. The company received 12 final approvals during 2010 which include approval for cefixime, imipramine hydrochloride, losartan potassium, famotidine, lamotrigine, desloratadine, etc. It also received tentative approval for 2 products.
Glenmark and is subsidiaries received highest number of final approval during 2010 which include approvals for products like norethindrone, trandolapril, verapamil hydrochloride, mometasone fuiroate, trospium chloride, adapalene, norethindrone, indomethacin, etc. The company's standalone R&D expenditure declined to Rs.51.85 crore from Rs.61.90 crore in the 2008-09. It signed an out-licensing agreement with sanofi-aventis for its molecule for neuropathic pain, GRC 15300 in May 2010. The company initiated US phase I trial on GBR 500, the first monoclonal antibody to enter the clinical trial phase.
Dr Reddy's Labs has received 11 final approvals in 2010 as against 16 in the previous year. The major approval was for desloratadine, lansoprazole, tacrolimus, anastrozole, mycophenolate mofetil, zafirlukast, etc. Its R&D spending declined by 7.5 per cent to Rs.389.70 crore from Rs.421.20 crore in the 2008-09.
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