Glenmark Pharmaceuticals Limited on Tuesday announced that it has received final approval from the United States Food & Drug Administration (U.S. FDA) for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, the generic version of Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc.
According to the company’s press statement, Glenmark’s Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIATM sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg market2 achieved annual sales of approximately $33.6 million.
Glenmark’s current portfolio consists of 181 products authorized for distribution in the U.S. marketplace and 47 ANDA’s pending approval with the U.S. FDA.