Higher investments in R&D activities, focus on new product launches in international market and loss of exclusivity may turn into strong presence in highly regulated markets like US and Europe. Indian pharmaceutical companies have successfully gained higher approval for ANDAs from US FDA during last couple of years. For the first half ended June 2017, Indian pharma companies received final approval for 138 ANDAs as against approval for 201 ANDAs during the full year ended December 2016. The US FDA approved total 387 ANDAs during first half as compared to 598 ANDAs in the full year 2016.

Similarly, Indian companies got 32 tentative ANDA approvals from US FDA during the first half ended June 2017 as compared to 70 ANDA in the full year ended December 2016. The US FDA approved total 85 tentative approvals during first half of 2017 as compared to 156 in the full year ended December 2016.

Aurobindo Pharma maintained its top position by securing 30 final approval from US FDA during the first half ended June 2017 followed by Zydus Pharma 21 ANDAs, Lupin and Gland Pharma 9 ANDAs each, Taro Pharma and Sun Pharma together 12 ANDAs, Macleods Pharma 7 ANDAs and Alkem Labs, Glenmark Pharma and Alembic Pharma 6 ANDAs each.

Aurobindo Pharma received highest number of 30 final and 5 tentative ANDA approvals from US FDA during the first half ended June 2017. Its R&D expenditure reached a Rs.543 crore and worked out to 3.6 per cent of revenue during 2016-17. Aurobindo's formulations business registered a growth of 9 per cent to Rs.12,045 crore from Rs.11,064 crore on account of healthy growth in the US and Emerging markets. Formulation sales accounted for 80 per cent of total revenues. Its US formulations sales increased by 12 per cent to Rs.6,827 crore from Rs.6,079 crore and accounted 45 per cent to the total revenues.

The company filed 31 ANDAs with US FDA including 19 in oral and 12 in injecjtable & ophthalmic category. On a cumulative basis, the company filed 429 ANDAs with US FDA and received approvals for 314 ANDAs including 38 tentative approvals. The company started filing oncology ANDAs and also entered in biosimilars through acquisition of 4 molecules from TL Biopharmaceuticals AG.

Dr Reddy's Laboratories got final approval for 5 ANDAs and one tentative approval in the first half of 2017. The company filed 26 ANDAs with US FDA during 2016-17 and cumulatively 101 generic filings are pending for approval. Its R&D expenditure touched to Rs.1,960 crore and worked out to 13.9 per cent of revenues against 11.5 per cent in 2015-16. focus continues to build sustainable revenue stream through a mix of simple and complex generics, biosimilars. and differentiated products pipeline.

Glenmark Pharmaceuticals received 6 final ANDA approvals during the first half ended June 2017 and 5 tentative approvals. The company's sales of formulations in India improved by 6.9 per cent to Rs.576.93 crore from Rs.539.77 crore and its US sales moved up by 53.5 per cent to Rs.1,000 crore from Rs.652 crore in the similar quarter of last year. US sales improved strongly mainly due to launch of Ezetimibe, the first and only generic version of Zetia (Merck) for the treatment of high cholesterol. The availability of Ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for Ezetimibe.

Glennmark has a pipeline of 7 new molecular entities (NMEs), which includes 2 new chemical entities and 5 new biological entities, in various stages of clinical development focused in the therapeutic areas of oncology, respiratory and dermatology. It has also 3 specialty products in clinical development targeting key indications in the respiratory therapy area.

Ajanta Pharma's R&D expenditure for the year 2016-17 increased to Rs.153 crore from Rs.106 crore in the previous year. It received 9 ANDA final approvals from US FDA and commercialized 7 products. It filed 8 ANDas with US FDA in 2017. For the full year ended March 2017, Ajanta Pharma's consolidated net sales increased by 11.9 per cent to Rs.1,933 crore from Rs.1,727 crore. Its net profit also moved smartly by 21.9 per cent to Rs.507 crore from Rs.416 crore. Its exports sales grew by 12 per cent to Rs.1,319 crore. Africa contributed Rs.712 crore, Asia contributed Rs.417 crore and US contributed Rs.185 crore. The sales in Asia declined by 10 per cent.

Alembic Pharma has received approvals for 4 ANDAs and its cumulative ANDA approvals reached at 52. The company filed 10 ANDA during the fourth quarter. Its cumulative filings of ANDA reached at 95. The company spent Rs.437 crore on R&D and filed 20 ANDA applications during 2016-17. Its international sales of formulation declined by 15.4 per cent to Rs.1,236 crore from Rs.1,461 crore and domestic sales improved 6.7 per cent to Rs.1,255 crore from Rs.1,176 crore.




US FDA approval in April-June 2017