Research based Indian pharmaceutical companies and their subsidiaries are increasingly cornering a large percentage of approvals for ANDAs from the US FDA during the last three years as per a compilation did by Pharmabiz. As per the US FDA figures, as many as 419 ANDAs were approved in 2009 and out of which Indian companies received 132 approvals. This works out 31.5 per cent of the total ANDAs approvals. Further, the US FDA approved 483 ANDAs and 492 ANDAs during 2008 and 2007 respectively. The total approvals of ANDAs during last three years were 1394 of which Indian companies received 408 approvals.
The Indian companies have invested huge funds in R&D and upgradation of facilities as per US FDA norms during last couple of years and now set to get returns in the form of higher approvals for their products. Indian pharmaceutical segment is the second largest US FDA approved facilities in the world after the US. The leading 25 companies incurred R&D expenditure of Rs 3210 crore during 2008-09 as compared to Rs 2747 crore in the previous year and this worked out to 7.8 per cent of sales in 2008-09.
These companies are entering US, the world's largest pharma market, aggressively with higher investments in R&D. Despite stringent approval system, Indian companies received better number of approvals during last three years and same is likely to increase in near future. Considering the list of blockbusters getting off-patent, these approvals will help to garner higher market share in US.
Aurobindo Pharma, a Rs 2965 crore pharma company from Hyderabad, got 18 ANDA approvals during 2009 and 6 tentative approvals from US FDA. This was followed by Dr Reddy's Laboratories and Sun Pharmaceutical Industries with 16 final approvals each. Sun's US based subsidiary – Caraco Pharma has not received any approvals during 2009. Zydus Pharma and Wockhardt received 14 final approvals each and one tentative approval. Glenmark Pharma's approvals stood at 10 ANDAs and it also received four tentative approvals.
The total final approvals of Aurobindo for the last three years i.e. 2009, 2008 and 2007 stood at 68 ANDAs and that of Dr Reddy's reached at 43 ANDAs. Sun Pharma and Caraco Pharma got 67 approvals and Zydus Pharma notched up 31 approvals during these three years. Alembic and Orchid Chemicals got six approvals each in 2009.
Ranbaxy, a subsidiary of Daiichi Sankyo of Japan, received seven final approvals during 2009 and its three-year tally reached at 24. Similarly, Matrix Laboratories, a subsidiary of Mylan Inc, received four final approval during 2009 and its aggregate figure of approvals reached at seven in last three years. Several Indian companies have set up subsidiaries in highly regulated market to take care of regulatory filings of new products. Further, mergers and acquisitions of foreign companies are also assisting well to improve presence and higher approvals from US authorities.
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