Glenmark Pharmaceuticals secures ANDA approval for 0.03 per cent Tacrolimus ointment, ET HealthWorld


Mumbai: Glenmark Pharmaceuticals Ltd., a pharmaceutical firm, has obtained final endorsement from the United States Food and Drug Administration (USFDA) for its Tacrolimus ointment, 0.03 per cent.

This ointment is the generic equivalent of Leo Pharma AS’s Protopic1 ointment, 0.03 per cent. The distribution of Glenmark‘s Tacrolimus ointment, 0.03 per cent, in the United States will be handled by Glenmark Pharmaceuticals Inc., USA.

Recent IQVIATM sales data covering the 12-month period concluding in June 2023 indicates that the market for Protopic® Ointment, 0.03 per cent, achieved yearly sales of approximately $15.4 million.

Glenmark’s existing assortment encompasses 184 products that have received authorisation for distribution in the U.S. market. Additionally, the company has 51 Abbreviated New Drug Applications (ANDAs) awaiting approval from the USFDA.

  • Published On Aug 17, 2023 at 03:03 PM IST

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