Glenmark Pharma receives ANDA approval for Clindamycin Hydrochloride

Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by 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® (all brand names and trademarks are the property of their respective owners) Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc. 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 market (market includes brand and all available therapeutic equivalents) achieved annual sales of approximately $33.6 million (IQVIATM National Sales Perspectives: Retail & Non-Retail, January 2023).

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. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.