Higher investments in R&D during the last couple of years has started yielding good results for R&D based Indian pharma companies in the current year. Indian companies received 55 ANDAs approvals from US FDA and 16 tentative approvals during the first quarter ended March 2017.
The US FDA approved total 171 ANDAs and gave 43 tentative approvals during the first quarter and Indian companies secured 32.2 per cent and 37.2 per cent respectively of aggregate approvals. Based on first quarter figures, the US FDA approvals may cross approval for 700 ANDA in 2017, highest in the last decade and growth of over 17 per cent in approvals over the previous year. Indian companies are poised to get a major portion of these approvals and may step up presence in highly regulated global markets. However, quality problem and related US FDA actions may impact operations of few Indian majors.
Aurobindo Phama remained on top with 13 ANDA approvals and three tentative approvals during the first quarter ended March 2017. Lupin and Zydus Pharma Group captured second and third spot with approval of six ANDAs each, followed by Gland Pharma 5, Alkem Laboratories and Macleods Pharma four each and Cipla three ANDAs. The list includes major companies like Dr Reddy's Laboratories, Sun Pharmaceutical, Unichem Laboratories, Wockhardt, Ajanta Pharma, Glenmark Pharma, Jubilant Generic and Panacea Biotec.
For the full year ended December 2016, the US FDA approved 598 ANDAs as compared to 564 in the previous year and 156 tentative approvals as against 147. Indian companies, with investments in R&D, received 201 final approvals and 70 tentative approvals during 2016.
Higher approvals from US FDA may help to clock double digit growth in 2016-17. The net sales of Pharmabiz sample of 30 leading pharma companies improved by 10.2 per cent to Rs.1,34,150 crore during nine months period ended December 2016 from Rs.1,21,691 crore in the corresponding period of last year. Their net profit after adjustments also moved up by 11.7 per cent to Rs.20,774 crore from Rs.18,600 crore though the interest burden went up by 34.5 per cent to Rs.3,387 crore from Rs.2,519 crore. EBDITA grew by 10.6 per cent to Rs.36,044 crore from Rs.32,594 crore in the same nine months of last year.
Aurobindo's robust product portfolio is spread over seven major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allelrgies and anti-diabetics, supported by a strong R&D set-up. Its R&D expenditure for the third quarter ended December 2016 increased to Rs.130 crore. The company now has a total of 314 ANDA approvals (276 final approvals including 16 from Aurolife Pharma LLC and 38 tentative approvals) from US FDA. Aurobindo's US sales for the first nine months ended December 2016 grew by 16.6 per cent to Rs.5,184 crore from Rs.4,445 crore in the same period of last year. Its European sales improved by 9.2 per cent to Rs.2,500 crore and that in emerging market moved up by 15.6 per cent to Rs.559 crore.
Lupin's R&D investment increased by 50 per cent to Rs.1,639 crore during first nine months of 2016-17 from Rs.1,093 crore in the same period during previous year. Cumulative ANDA filings with the US FDA stood at 344 and it received 207 approvals up to the end of December 2016. It now has 44 First-to-File filings including 23 exclusive FTF opportunities. Similarly, cumulative DMF filings stand at 173. The company also filed 2 MAA with the European authority during the quarter ended December 2016. Cumulative filings with European authorities now stands at 66 with the company having received 54 approvals.
Alkem Laboratories, a Rs.3,850 crore plus pharma major from Mumbai, has stepped up its R&D expenditure during the first nine months ended December 2016 to Rs.229 crore or five per cent of total operating income. It received five approvals during first nine months and cumulative filing reached 77 ANDAs and one new drug application (NDA) with US FDA of which 33 are Para IV filings including first-to-files. The company received total 35 ANDAs (including 08 tentative approvals) and 1 NDA.
Zydus Pharma Group belonging to Cadila Healthcare, has received total six ANDA approvals during the first quarter ended March 2017 from US FDA. Its R&D expenditure formed over 7.5 per cent of its operating revenues. It filed an aggregate of 305 ANDAs upto the end of December 2016, of which over 75 are para IV filings. Cadila received approval for 107 ANDAs and currently 198 ANDAs are pending for approvals. It generated over 85 per cent revenue from formulations business across India, US and other markets. Further, it also filed 128 US DMFs upto the end of December 2016. Its 18 biosimilars and seven novel products are in pipeline and 10 vaccines are under pipeline. It received authorizations for nine vaccines of which it already launched three in the market. It's five NCEs are in the pipeline.
Sun Pharma has total 424 ANDA approvals from US FDA as at the end of December 2016 and 149 ANDAs await approvals, including 14 tentative approvals. Additionally, the pipeline includes 36 approved NDAs while four NDAs await US FDA approval. Glenmark Pharma has a pipeline of seven new molecular entities, which includes two new chemical entities and five new biological entities, in various stages of clinical development focused in the therapeutic areas of oncology, respiratory, disease and dermatology. The company also has three speciality products in clinical development targeting the key indications in the respiratory therapy area. Thus the R&D efforts of Indian pharma companies will offer better returns in the long run.