Aurobindo Pharma receives final approval for Clindamycin Hydrochloride capsules

Aurobindo Pharma has received the final approval for Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg (base) from the US Food and Drug Administration (USFDA),

Clindamycin Hydrochloride capsules USP 150mg (base) and 300mg (base) are generic equivalent to Cleocin Hydrochloride capsules 150mg (base) and 300mg (base) of Pharmacia and Upjohn Company.

Clindamycin Hydrochloride is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria and falls under the anti-infective therapeutic segment.

The product has market size of approximately $55 million for the 12 months ending March 2009 according to Newport. The product will be launched in the US market shortly.

Aurobindo now has total of 101 ANDA approvals which comprises of 73 final approvals and 28 tentative approvals from USFDA.

Aurobindo, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s robust product portfolio is spread over six major therapeutic areas comprising antibiotics, anti-retrovirals, CVS, CNS, Gastroenterologicals and anti allergic.