Gujarat pharma firms lag behind industry majors in USFDA approvals

Gujarat-based pharmaceutical majors are yet to catch up with national players this fiscal when it comes to getting drug approvals from the US drug regulator.

While players like Aurobindo Pharma secured around 24 abbreviated new drug applications (ANDA) approvals during the year, while Strides Acrolabs and its subsidiary Onco Therapies received 18 approvals, Sun Pharmaceuticals and its subsidiary Taro Pharma got 15 approvals.

In comparison, Ahmedabad based Torrent Pharma received four ANDA approvals till December, shared a company spokesperson. This is lower compared to last fiscal when the company received 11 approvals. 

Intas Pharma, a privately held player received seven approvals during the year taking the cumulative approvals by the US Food and Drug Administration (USFDA) to around 35, informed Jayesh Shah, chief financial officer, Intas Pharma. He added that the US contributes to around 20 per cent of its net sales and is thus an important market for the company. 

 

Vadodara-based Alembic Pharma, which is now focussing on regulated markets, has, however, managed to double its number of ANDA approvals this financial year. The company has received four approvals in the first nine months of the fiscal compared to two approvals during 2011-12. A company spokesperson also claimed that another four are expected during the fourth quarter. 

City-based global player Cadila Healthcare, however did not share the details of the number of approvals received till December. The company's cumulative approvals in the US till September 2012 was 72. US operations contribute around 25 per cent of its turnover. 

On the whole, Indian companies have received around 178 ANDA approvals during the year as compared to 144 in the previous year, said a report on Indian Pharmaceutical sector by India Rating, a Fitch Group company. The USFDA granted total 476 ANDAs approvals during the year 2012 as against 431 approvals in the previous year. Of these total US FDA approvals, Indian companies grabbed 37.4 per cent approvals in 2012 as against 33.4 per cent in the last year.