Mumbai: Aurobindo Pharma on Thursday said it has received regulatory approval in the US for making and marketing low-cost anti-infection drug Clindamycin Hydrochloride.
Besides, the drug maker has also received the Swiss government’s nod for the licence of Cefepime APL injection, used in the treatment of various diseases, including pneumonia and skin-related infections.
The US Food and Drug Administration has given its final approval to the company for Clindamycin Hydrochloride capsules in the strengths of 150mg and 300mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange (BSE).
Clindamycin capsules are generic equivalent of Pharmacia and Upjohn company’s Cleocin Hydrochloride capsules. According to an estimate for the 12-months ending March 2009, the product has a market size of about $55 million.
“The product will be launched shortly,” Aurobindo said. After this approval, the Indian firm now has a total 101 approvals from the US drug regulator, which includes 73 final approvals and 28 tentative.
The Swiss regulatory approval for Cefepime injection is in the strengths of 1g and 2g. This is Aurobindo’s second product approval from Swissmedic, the company said.
Shares of Aurobindo were trading at Rs714, down 0.21% in the afternoon trade on the BSE.