Glenmark Pharma gets sANDA approval for Tacrolimus Ointment

17 Aug 2023 , 11:51 AM

Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led, integrated global pharmaceutical company, has received the final United States Food & Drug Administration (USFDA) approval for Tacrolimus Ointment, 0.03%, the generic version of Leo Pharma AS’s Protopic1 Ointment, 0.03%. 

Glenmark Pharmaceuticals Inc., USA will distribute Glenmark’s Tacrolimus Ointment, 0.03%, in the United States.

According to IQVIATM sales statistics for the 12-month period ending June 2023, the Protopic Ointment, 0.03% market2 generated roughly $15.4 million in annual sales.

Glenmark said that its current portfolio of products includes 184 medications that are permitted for distribution in the United States, as well as 51 ANDAs that are awaiting USFDA approval. Glenmark continues to identify and explore external development collaborations to enhance and expediate the expansion of its existing pipeline and portfolio, in addition to these internal filings.

At around 11.45 AM, Glenmark Pharmaceuticals was trading 1.94% higher at Rs 782, against the previous close of Rs 797.45 on NSE. The counter touched an intraday low of Rs 776.85.

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