Indian pharmaceutical companies and their subsidiaries have successfully spread their presence in highly regulated markets like United States (US), Europe and even in emerging markets through investments in Research and Development (R&D) activities. The Indian companies have received higher number of US Food & Drug Administration (FDA) approvals for 178 Abbreviated New Drug Applications (ANDAs) during 2012 as compared to 144 in the previous year despite stringent approval norms. Further, these companies got 42 tentative approvals during 2012 as compared to 49 in the preceding year.

The US FDA granted total 476 ANDAs approvals during the year 2012 as against 431 approvals in the previous year. Of these total US FDA approvals, Indian companies grabbed 37.4 per cent approvals in 2012 as against 33.4 per cent in the last year. The total number of tentative approvals stood at 94 during 2012 as compared to 117 in the previous year.

Aurobindo Pharma, a Rs.4,550 crore plus pharma major from Hyderabad, has secured highest numbers of 24 ANDAs approvals during 2012. This was followed by Dr Reddy's Laboratories with 19 approvals, Strides Arcolab and its subsidiary Onco Therapies 18, Sun Pharmaceuticals and its subsidiary Taro Pharmaceuticals 15, Macleods Pharma 12, Wockhardt 11, and Glenmark Generic, subsidiary of Glenmark Pharmaceuticals and Lupin secured 10 approvals each. Further, Torrent Pharmaceuticals, and Emcure Pharmas received eight and seven ANDAs approvals each during 2012. Alembic Pharmaceuticals and Orchid Chemicals & Pharmaceuticals got five ANDAs approvals each.

Aurobindo Pharma filed 17 ANDA in USA during the first half ended September 2012 taking cumulative filings to 265 ANDAs. Further, it filed six DMFs and its cumulative filing reached at 170. Following approvals, its cumulative approvals reached at 162 in USA, 34 in Australia and 23 in Canada during the second quarter ended September 2012. For the first half ended September 2012, Aurobindo's consolidated net sales increased by 26.6 per cent to Rs.2,678 crore from Rs.2,116 crore. Its EBDITA improved by 36.5 per cent to Rs.398.84 crore from Rs.292.11 crore in the same period of last year.

Dr Reddy's Laboratories has filed four ANDAs in the second quarter ended September 2012 and its 63 ANDAs are pending for approval with the US FDA. Its R&D expenditure reached at Rs.180 crore and worked out to six per cent of revenues. It filed 10 DMFs globally, including two in Europe. The cumulative number of DMF filings reached at 552.

Strides Arcolab has received US FDA approval for its Polish Sterile facility and expects to launch new product in the current quarter. With this approval, its all nine sterile sites were approved by US FDA. The company commercialized eight new ANDAs including day one launch of Oxaliplatin. It filed 28 sterile ANDAs during the third quarter of 2012 and its cumulative ANDA filings reached at 232. Its Agila Specialties division recorded revenues of Rs.1,000 crore during the first nine months ended September 2012. The division contribute over 60 per cent to Group's revenue.

Glenmark Pharma has filed five ANDAs with the US FDA during the quarter ended September 2012. Glenmark's marketing portfolio, consists of 81 generic products authorised for distribution in the US market. It has 43 applications pending in various stages of the approval process with the US FDA, of which 19 are Paragraph IV applications. The company has five NCE and NBE molecules in clinical trials including in-licensed molecule 'Crofelemer.' For the first half ended September 2012, Glenmark's consolidated net sales increased by 19.3 per cent to Rs.2296 crore from Rs.1924 crore in the same period of last year. However, its net profit declined by 11.4 per cent to Rs.235.03 crore from Rs.265.17 crore.

With improved R&D productivity, Ranbaxy Laboratories has made 31 dosage form filings and received 43 approvals. It filed 12 DMFs with US FDA during the quarter ended September 2012 and it received approval to set up a greenfield manufacturing facility in Malaysia. During the quarter, 14 regulatory agencies from across the globe inspected Ranbaxy's facilities, in various location across the world, including India.

Lupin's revenue expenditure on R&D stood at 4.2 per cent of net sales at Rs.93.5 crore during the quarter ended September 2012 as compared to Rs.138.0 crore. The lower R&D expenditure is due to lower expenditure towards legal and professional charges incurred during the quarter. Its capital expenditure stood at Rs.127.7 crore. The company filed two ANDAs and its cumulative ANDA filings with the US FDA stood at 178 and it received total 65 approvals so far.

The overall R&D expenditure of 30 Indian companies increased by 19.6 per cent to Rs.4,678 crore in the year ended March 2012 from Rs.3,912 crore in the previous year. This worked out to 7.2 per cent of their standalone net sales of Rs.65,001 crore in 2011-12. Dr Reddy's Laboratories remained on top with R&D spending of Rs.624 crore during 2011-12 followed by Lupin Rs.594 crore, Ranbaxy Laboratories Rs.470 crore, Cadila Healthcare Rs.401 crore and Cipla Rs.324 crore. With higher expenditure on R&D, Indian companies are well set to overcome competition in the field and expiration of patents will create huge opportunities in the coming years.



ANDAs Approved in 2012