Glenmark Pharma bags USFDA nod for generic version of Cleocin Hydrochloride Capsules

Mumbai: Glenmark Pharmaceuticals Limited 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 product is the generic version of Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, of Pfizer Inc.

Clindamycin Hydrochloride capsules are used for the treatment of bacterial infections of the skin, blood, lungs, female reproductive organs, and internal organs. This medicine may be given to patients who have had an allergic reaction to penicillin. Clindamycin will not work for flu, colds, or other virus infections.

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 IQVIA sales data for the 12-month period ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg market 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.

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