Glenmark Pharma Receives U.S. FDA Approval For Generic Antibiotic Drug

Glenmark Pharmaceuticals Ltd. on Tuesday said it has received approval from the U.S. health regulator to market a generic antibiotic drug.

The company has received final approval from the U.S. Food and Drug Administration for Clindamycin Hydrochloride Capsules, a generic version of Pfizer Ltd.'s Cleocin capsules, Glenmark Pharma said in a statement.

Glenmark's Clindamycin Hydrochloride Capsules in strengths of 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc, it added.

According to IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg achieved annual sales of around $33.6 million.

Glenmark shares were trading 0.12% up at Rs 426.10 apiece on the BSE.