Aurobindo Pharma gets USFDA nod for two drugs

Hyderabad : 

Homegrown pharma player Aurobindo Pharma Limited on Saturday informed the bourses that the company had received USFDA’s (United States Food and Drug Administration) final nod to manufacture and market tamsulosin hydrochloride capsules and clindamycin palmitate hyderochloride  for oral solution in the US market.

The Hyderabad-headquartered company did not disclose the timeline but said that the products would be launched soon.

Tamsulosin hydrochloride capsule is the generic version of Boehringer Ingelheim Pharmaceuticals’ Flomax capsules and is indicated for the treatment of symptoms of enlarged prostate in men. According to industry estimates, the market size of the product is estimated to be $244 million for the twelve months ending September 2012.

Clindamycin Palmitate Hydrochloride for oral solution is the copycat version of Pharmacia  & Upjohn’s Cleocin Pediatric for oral solution and is indicated for the treatment of serious infections caused by susceptible anaerobic bacteria in infants.

Industry estimates state that the market size of the product is $57 million for the twelve months ending September 2012.

According to the company, Aurobindo now has a total of 190 Abbreviated New Drug Application (ANDA) approvals from the US regulator USFDA .

source: http://www.timesofindia.indiatimes.com / The Times of India / Home> Business> India Business / TNN / May 04th, 2013

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