The Indian pharmaceutical companies and their subsidiaries have established strong presence in the United States and other regulated markets with higher investment in research and development (R&D) during the last couple of years. Indian companies received final approval for 154 ANDAs during the year 2013 from US FDA and 38 tentative ANDAs approval during 2013.
The US FDA has approved a total 400 final ANDAs during the year 2013 as against 476 in the previous year and it approved total 86 tentative ANDAs during 2013 as against 94 during 2012. Out of the total approvals, Indian companies grabbed 38.5 per cent final approval during 2013 as against 37.4 per cent in the previous year. Similarly, Indian companies received 44.2 per cent of total tentative approvals as compared to 42 per cent in the previous year.
The US FDA final approval of 400 ANDAs during 2013 was the lowest in the last five years. During 2012, it approved 476 ANDAs as against 431 ANDAs in 2011. It approved 418 ANDAs in 2010 and 419 during 2009.
Sun Pharmaceutical Industries and its subsidiaries viz, Taro Pharmaceutical Industries and Caraco Pharmaceutical Laboratories, received highest number ANDAs approvals from US FDA during 2013. Sun Pharma and its subsidiaries received 30 ANDAs approvals followed by Lupin 21, Aurobindo Pharma 19, Dr Reddy’s Laboratories 14, Emcure Pharmaceuticals 13, Glenmark Generics 8, Torrent Pharmaceuticals 6, Cadila Healthcare Group and Claris Lifesciences 5 each. Alembic Pharmaceuticals and Hetero Laboratories received 4 ANDAs approval each during 2013. Ipca Laboratories, Jubilant Life Sciences, Strides Arcolab and Alkem Labs received 3 approvals each. Other major companies like Ranbaxy Laboratories received only one approval and Wockhardt, Cipla, Macleods Pharma and Micro Labs received 2 approvals each during 2013.
Lupin received highest tentative approval for 10 ANDAs during 2013 and was followed by Aurobindo Pharma 6, Sun Pharmaceuticals 5 and Alembic Pharmaceuticals 4. Further, Zydus Pharma received 3 tentative approvals during 2013.
Indian companies are investing in R&D to tap profitable regulated market with higher approval for ANDAs and DMFs. The company filed 13 ANDAs with US FDA and its cumulative filings reached at 294. Similarly, it filed 8 DMFs during the second quarter and cumulative total reached at 175. Further, it filed 47 API DMF/COS in other key regulated market. The cumulative approvals in US stood at 184 ANDAs, followed by South Africa 64, Australia 46, and Canada 39. For the first half ended September 2013, Aurobindo’s consolidated net sales moved up by 34.3 per cent to Rs.3,597 crore from Rs.2,678 crore in the similar period of last year. Its net profit went up sharply to Rs.253.55 crore from Rs.93.44 crore, a growth of over 171 per cent.
Lupin’s R&D expenditure increased sharply to Rs.217 crore during the second quarter ended September 2013 from Rs.93.5 crore and it worked out to 8.3 per cent of net sales. It filed 7 ANDAs and received approval for 6 ANDAs during the quarter under review. Cumulative ANDA filings with the US FDA now stand at 183 with the company having received 92 approvals to date. It also received first MAA approval from European regulatory authorities in the quarter.
For the first half ended September 2013, Dr Reddy’s Laboratories R&D expenditure increased by 64 per cent to Rs.544 crore from Rs.332 crore. As of the end of September 2013 quarter, it filed 4 ANDAs and 62 ANDAs are pending for approval with the US FDA.
Orchid Chemicals has filed 43 ANDAs in US up to September 2013 and received approval for 32 ANDAs. Similarly, it filed 30 marketing authorizations in the EU region and received 30 approvals. The company filed 90 DMFs in US and 21 filings in European market. It filed 8 DMFs globally, including one each in the US and Europe. The cumulative number of DMF filings as of end of September stood at 590.
Thus, the Indian companies have successfully stepped up the ANDA filings and approvals form US FDA during 2013 and now set to spread there business operations in the highly regulated markets. Despite quality problem regarding few major players, the Indian companies will able to generate better level of revenues with higher approval rates.