The year 2015 marked by a significant higher US FDA approvals for ANDAs as compared to steady decline in approvals during the last couple of years. The US FDA approved total 564 ANDAs in 2015 as compared to 385 ANDAs in 2014 and 400 ANDAs in 2013. The ANDA approvals went up sharply by 46.5 per cent during 2015 as compared to declined of 3.8 per cent in 2014 and 16 per cent in 2013.

With higher investments in R&D expenditure and focus on new product launches, Indian pharmaceutical majors and their subsidiaries secured 167 ANDA approvals in 2015 as compared to 130 ANDAs and 154 ANDAs in 2014 and 2013 respectively. Indian companies registered strong growth of 28.5 per cent in ANDA approvals as compared to decline of 15.6 per cent in 2014 and 13.5 per cent in 2013. However, the percentage of India pharma companies in total approvals declined in 2015 to 29.6 per cent from 33.8 per cent in 2014 and 38.5 per cent in 2013 may be due to warning letters issued to several Indian players in last few years.

The tentative approvals by US FDA also increased by 47 per cent in 2015 to 147 approvals from 100 approvals in 2014 and 86 approvals in 2013. Indian companies received 48 tentative approvals during 2015 as against 100 tentative approvals in 2014 and 86 approvals in 2013.  

A Pharmabiz study of leading 25 companies shows that there is a 28.8 per cent growth in R&D expenditure at Rs.9,250 crore during the year ended March 2015 from Rs.7,179 crore in the previous year. These companies have spent almost seven percent of their consolidated net sales in 2014-15, which is slightly higher from 6.6 per cent in the previous year. These companies have created strong product pipeline by filing ANDAs, DMFs and patents in the world market.

Aurobindo Pharma, a fourth largest Indian pharmaceutical company by sales of Rs.12,000 crore, has secured highest number of ANDA approvals during 2015 and it got total 33 ANDA approvals. Lupin, the third largest pharma company, received approvals for 29 ANDAs. Macleods Pharma, a Mumbai based unlisted pharma major with presence in more than 80 countries, has received 12 ANDA approvals from US FDA in 2015. Jubilant Generics, Alembic Pharma, Glenmark Pharmaceuticals and Hetero Labs received more than 10 ANDA approvals each. Sun Pharmaceuticals and Torrent Pharma secured 8 ANDA approvals each.

As at the end of December 2015, Aurobindo has a total of 252 ANDA approvals (216 final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, anti-allergies and anti-diabetics, supported by an outstanding R&D set-up. Recently, Aurobindo received approvals to manufacture and market Polymyxin B for injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17.

Lupin's revenue expenditure on R&D during the first nine months ended December 2015 increased to Rs.1,093 crore from Rs.789 crore in the previous year, a strong growth of 38.5 per cent. The company received ANDA approvals for 29 ANDAs in 2015 as compared to 13 ANDAs in the previous year. The company's Goa facility was inspected by the US FDA recently and FDA issued 9 observations regarding inadequacy and adherence to standard operation procedures (SOPs). This may impact its working in current year and also approvals by US FDA. Its cumulative ANDA filings stood at 225 as on December 31, 2015. It has 37 First-to-File products which includes 17 exclusive FTF opportunities. Similarly its cumulative filing in Europe stand at 64 and it received approvals for 55 approvals from European Authorities.

Glenmark Pharmaceutical filed 6 ANDA applications with the US FDA during the first nine months ended December 2015 and it intends to file another 6-8 ANDA applications in the current quarter. As of December 2015, its portfolio consists of 104 generic products authorized for distribution in the US market. It currently has 63 applications pending in various stages of the approval process with the US FDA of which 26 are Paragraph IV applications. The company has pipeline of 3 NCE and 5 NBE molecules in clinical trials or ready to enter clinical trials soon, including the in-licensed molecule 'Crofelemer'.

Dr Reddy's Laboratories R&D expenditure increased to Rs.1,296 crore during the first nine months ended December 2015 from Rs.1,230 crore in the similar period of last year. DRL continued focus on building complex generics and differentiated products pipeline. Currently, 82 generic filings are pending for approval with the US FDA. Of these 79 ANDAs, 52 are Para IVs out of which it believe 18 have 'First-to-File' status.

Besides, above mentioned Indian pharma majors, Sun Pharmaceutical, Cipla, Jubilant Life Sciences, Torrent Pharmaceuticals, Cadila Healthcare, Wockhardt, Biocon, Strides Shasun, etc are stepping up their R&D expenditure and well set to increase ANDAs in US.

For the first quarter ended March 2016, US FDA approved 151 ANDAs and out of this Indian companies grabbed 50 ANDA approvals. Similarly, US FDA approved 36 tentative approval for ANDAs and Indian companies secured 19 tentative approvals. Thus, the R&D investments by Indian pharma companies are well set to push more approvals from US FDA in the current year.

Final table ANDA Approvals in 2015