Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg

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Glenmark Pharmaceuticals
Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300mg

Bangalore, India and Mahwah, New Jersey, March 14, 2023 – 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®1 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 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. 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.