Popular Posts

Sunday, 8 April 2018

FDA Updates: Indian pharma companies secure 51 final ANDA approvals during Jan-March 2018- Aurobindo Pharma on Top

Indian companies have secured 51 final ANDA approvals from US FDA during the first quarter of January-March 2018, out of total 112 approvals. This worked out to 45 per cent of total approvals in the first quarter. During the same period last year, Indian companies had grabbed 55 final ANDA approvals out of 171 approved by US FDA. Further, Indian companies received 6 tentative approvals from aggregate 23 tentative approvals in the first quarter of Jan-March 2018. The overall approvals declined to 112 ANDAs from 171 ANDAs in the same quarter of last year and 23 tentative approvals as compared to 43 tentative approvals. 
Aurobindo Pharma has received the highest numbers of ANDA approvals among the Indian companies during the first quarter of 2018. It received 11 final ANDA approvals followed by Strides Shasun 6, Lupin 5, Cipla and Zydus Pharma 4 each, Dr Reddy's Laboratories, Hetero Labs and Taro Pharma 3 each. Macleods Pharma and Vivimed Global received 2 approval each. Alkem Laboratories, Gland Pharma, Glenmark Pharma, Granules India, Jubilant Life, Laurus Labs, Micro Labs and Torrent Pharma received one ANDA approval each in the first quarter. 

For the full year ended December 2017, Indian companies obtained 304 ANDA approvals out of 846 approvals by US FDA and 61 tentative approvals from 172 approvals. Among the Indian companies Zydus Pharma USA, received highest approvals of 66 ANDAs in 2017 followed by Aurobindo at 51 and Glenmark Pharma at 18. 

Leading Indian companies are investing huge amounts in R&D expenditure to meet international competition and filing new products in highly regulated market like US and Europe. Lupin, Dr Reddy's Laboratories, Alkem Laboratories, Biocon, Cadila Healthcare, Sun Pharmaceuticals, Ajanta Pharma, etc, set to overcome competition in the international field.Lupin's aggregate revenue R&D expenditure during the first nine months ended December 2017 declined to Rs.1,450 crore from Rs.1,639 crore. Lupin filed 5 ANDA and received 6 approvals from the US FDA during the third quarter. Its cumulative ANDA filings with the US FDA stood at 382 as of December 31, 2017, with the company having received 231 approvals to date. The company now has 33 First-to-Files (FTF) filings including 16 exclusive FTF opportunities. 

Dr Reddy's Laboratories R&D expenditure declined to Rs.1,392 crore from Rs.1,497 crore during the nine months period ended December 2017. As at the end of December 2017, DRL's 102 generic filings were pending for approval with the US FDA (99 ANDAs and 3 NDAs).

Alkem Laboratories' R&D expenditure increased to Rs.252.9 crore during first three quarter ended December 2017 from Rs.228.9 crore and worked out to 5.1 per cent of total revenue. Thus, it filed total 96 ANDAs upto end of December 2017 of which 41 are Para IV filings including first-to-files. It received total approvals for 48 ANDAs. All the 6 manufacturing facilities catering to the US market have an EIR with no pending observations in any of them. 

Biocon's Research and Development expenses declined by 18 per cent to Rs.165 crore during first nine months ended December 2017 from Rs.201 crore. Cadila received approval for 24 new products for the US market from US FDA during the quarter ended December 2017 and filed 10 additional ANDAs with the US FDA. It launched 2 new products in the US during the quarter.

Alembic Pharma's R&D expenditure declined to Rs.98 crore during third quarter ended December 2017 from Rs 121 crore in the last period. It received one ANDA approval during the December quarter and its cumulative total reached at 63 ANDA approvals. The company filed 4 ANDAs and its cumulative ANDA filings reached at 108 (119 with Orit acquisition.). It launched two new products in US.

Thus Indian companies are well set to grab future opportunities in the highly regulated market. Despite US FDA actions regarding quality during last couple of years, India pharma companies are well in a position to launch new products.