Mumbai-based Glenmark Pharmaceuticals, one of the top 10 pharmaceutical companies in India, announced on March 14, 2023, that the United States Food and Drug Authority (USFDA) has approved the company’s abbreviated new drug application (ANDA), which usually contains data which is submitted to FDA for the review and potential approval of a generic drug product for Clindamycin Hydrochloride Capsules in multiple fixed doses.
The company informed that it received USFDA approval for Clindamycin Hydrochloride Capsules USP, in 75 mg, 150 mg, and 300 mg, the generic version of Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg, manufactured and marketed by Pfizer Inc.
The company further informed that its Clindamycin Hydrochloride Capsules USP, 75 mg, 150 mg, and 300 mg, will be distributed in the United States by its US arm, Glenmark Pharmaceuticals Inc. USA.
According to IQVIATM sales data for the 12 months ending January 2023, the Cleocin Hydrochloride Capsules, 75 mg, 150 mg, and 300 mg market achieved annual sales of approximately 33.6 million US dollars.
It may be recalled that Glenmark’s current portfolio consists of 181 products authorised for distribution in the US marketplace, and 47 formulations are awaiting ANDA approval with the USFDA.
In addition to these internal filings, Glenmark said that it is continuing to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
