Indian pharmaceutical companies and their subsidiaries received 304 final ANDA approvals from US FDA during 2017 as compared to 201 ANDA approvals in the previous year. The US FDA approved total 846 ANDA during 2017 which remained highest during last decade. Indian companies with enhanced R&D investments during last couple of years, managed to secured almost 36 per cent of total approvals by US FDA. Further, US FDA approved 171 tentative approvals and out of this Indian companies grab 61 tentative approvals in 2017. Higher rate of approvals for Indian companies will translate into higher revenues in near future.
During the last decade viz., 2008-2017, US FDA approved total 5,020 ANDAs and 1184 tentative approvals. Out of this, Indian companies grab 1,695 ANDA approvals and 455 tentative approvals. The average rate of securing approvals by Indian pharma companies worked out to almost 34 per cent for last decade. Thus, Indian pharma companies received healthy product approvals from highly regulated US body which will turned into higher export earnings.
Among the Indian pharma companies, Cadila Healthcare and its US based subsidiary remained on top in securing highest number of approvals during 2017. Cadila Healthcare and its US based subsidiary Zydus Pharmaceutical USA, Inc, have secured approvals for 71 ANDAs during 2017 and followed by Aurobindo Pharma (51), Sun Pharma & Taro Pharma (21) Glenmark Pharmaceutical (18), Gland Pharma (16), Alkem Laboratories (15), Macleods Pharma (15), Lupin (13), and Cipla and Dr Reddy's Laboratories 10 each. Further, Strides Shashun and Alembic Pharma received 9 ANDA approvals from US FDA during 2017.
Though the Indian pharma majors have faced quality problems raised by US FDA and getting warning letters as well as ban on exports, Indian companies have taken steps to overcome the same and invested higher funds in research activities. Higher investment in R&D helped them to secure higher number of product approvals. The US market is key growth driver for Indian pharma companies and actions or ban on Indian products may impact working and share price movements. Several Indian pharma giants suffered heavily during 2017 due to the US FDA actions.
Cadila Healthcare research activities is spread across five broad segments viz. NCE, biologics, vaccines, APIs and formulations development. Focused areas of NCE research include cardio-metmabolic disorder, inflamation, pain and oncology. It initiated phase II clinical trials of Saroglitazar Magnesium (Lipaglyn) in US for two indications viz. Non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia. Its biologics R&D initiative includes 18 biosimilars and 7 novel products as at the end of March 2017. It completed phase III clinical trials for one more monoclonal antibody (mAb).
Apart from ANDA approvals, Cadila is also developing vaccine portfolio and it received marketing authorization for seven additional vaccines from DCGI. The company has setup 32 manufacturing facilities across the globe, 27 of them located in India, 3 in the US, and one each in Brazil and Germany. Out of total 32 facilities, 11 have been inspected by the US FDA.
Aurobindo Pharma’s product portfolio is spread over 7 major therapeutic/product areas encompassing antibotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allegies and anti diabetics, supported by R&D setup. It received 51 final ANDA approvals during 2017. Recently it received final approval for manufacture and market fondaparinux sodium injections. This is 52nd ANDA to be approved out of Unit IV formulation facility in Hyderabad. It has a total of 350 ANDA final approvals from US FDA and 37 tentative approvals. Its subsidiary Aurolife Pharma LLC received 17 approvals.
Glenmark Pharma is currently marketing 126 generic products in US market. It has 61 applications pending in various stages of the approval process with the US FDA, of which 28 are Paragraph IV applications. During the second quarter ended September 2017, it received eight final approvals taking the tally to 13 final approvals for the first half of this financial year. It filed three ANDA applications with US FDA and plans to file an additional seven applications in the forthcoming quarter. It also filed 2 US DMFs and 1 EU CEP and completed several other regulatory filings in other key markets including Brazil and South Korea.
During the September 2017 quarter, Glenmark entered into a development, license, manufacture and commercial supply agreement with Cyndea Pharma SL. Under this agreement, Glenmark received exclusive rights to the US and Canada markets for these soft-gelatin formulations in exchange for sharing development costs and profits from future sales.
Lupin's R&D expenditure declined to Rs.973 crore during the first half ended September 2017 from Rs.1,071 crore in the corresponding period of last year. Its cumulative ANDA filings with the US FDA stood at 377 as of September 30, 2017 and it received 225 approvals upto first half. It now has 49 First-to-Files filings including 25 exclusive FTF opportunities. Cumulative DMF filings stands at 188 as of end of September.
During the quarter, on the R&D side, we made significant progress. GBR 830, an investigation, first-in-class, anti-OX40 monoclonal antibody, reported positive data in a phase 2a for the treatment of patients with Atopic Dermatitis. After reporting positive phase 3 data on GSP 301, we continue to make progress towards filing the NDA in 2018. This will be the first NDA filed by the organization.”
Alkem Laboratories R&D expenditure for the first half ended September 2017 reached at Rs.160 crore, or 5.1 per cent of total revenue from operations. The company is strengthening its R&D activities to strengthen product pipeline. Its US sales increased to Rs.304 crore during first half of 2017-18. The company received 15 final ANDA approvals from US FDA in 2017.
Wockhardt's R&D expenditure was at Rs.149 crore during the first half ended September 2017 and it received 5 ANDA approvals in 2017. Its net sales declined sharply by 11.3 per cent to Rs.1,913 crore from Rs.2,156 crore. International business contributed 61 per cent of the total revenues in the first half. Its US sales stands at 16 per cent of its global revenue.
Besides above pharm companies, Jubilant Lifesciences, Ajanta Pharma, Micro Labs, Unichem Laboratories, Torrent Pharma, Natco Pharma, Orchid Pharma, Panacea Biotic, Granules India, Hetero Labs, Intas Pharma, Marksans Pharma and Vintage Pharma also received approvals from US FDA in 2017.
US FDA ANDA Approvals for Indian Cos in 2017