Despite stringent approval systems in regulated markets, Indian pharmaceutical companies have been able to obtain increasing number of drug approvals from the US FDA during last few years. This has been possible for the Indian companies with strategic alliances with international giants and adopting innovative funding models to push R&D activities.

During the first half of 2010, twenty Indian pharma majors and their subsidiaries received 72 US FDA approvals for original Abbreviated New Drug Applications (ANDAs) as against 80 approvals for 21 companies in the corresponding period of last year. Glenmark Pharmaceuticals, a Rs 2475 crore plus pharma giant, has received highest number of approvals for nine ANDAs during the first half of 2010. This was followed by Lupin with approvals for eight ANDAs and seven each by Aurobindo Pharma, Dr Reddy's Laboratories, Matrix Laboratories (now subsidiary of Mylan Inc) and Sun Pharmaceuticals.

Claris Lifescieinces, Fresenius Kabi Oncology, Strides Arcolab, Wockhardt and Zydus Pharma received three ANDAs approval each during first half. Alembic, Emcure Pharma and Torrent Pharma got two ANDAs approvals. Alkem, Granules India, Hetero Drugs, Natco Pharma, Orchid Chemicals and Unichem Laboratories received one approval each. With investments in R&D, Indian companies are set get more and more approvals in the regulated market.

Recently, Glenmark Generics Inc, USA, a subsidiary of Glenmark Generics Ltd, have been granted final approval by the United States Food and Drug Administration (US FDA) for norethindrone tablets 0.35mg, their generic version of Micronor tablets by Ortho McNeil Janssen Pharmaceuticals, Inc..

Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy. Total sales of this niche generic contraceptive product were USD 43 million for the 12 month period ending March 2010, according to IMS Health.

Pharmaceutical and biotechnology major, Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing the 25mg, 50mg, 100mg and 200mg extended-release tablets of metoprolol succinate which is used for 24-hour control of hypertension, treatment of angina and in improvement of survival after heart attack. metoprolol succinate is the generic name for the brand Toprol XL, marketed in the United States by Astra Zeneca. The product is being launched immediately.

Strides Arcolab Ltd received the US FDA approval for sumatriptan succinate injection 6 mg (base)/0.5 mL. The drug is a selective agonist for a vascular 5-hydroxytryptamine1 receptor subtype. It is used for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes.

Lupin Ltd's US subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received the final approval for the company's Abbreviated New Drug Application (ANDA) for its lamotrigene tablets, 25 mg, 100 mg, 150 mg and 200 mg strengths, from the US Food and Drug Administration.


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