Glenmark Pharma gets ANDA approval for Tacrolimus Capsules

It is the generic version of Prograf Capsules of Astellas Pharm

Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (US FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg and 5 mg, the generic version of Prograf Capsules, 0.5 mg, 1 mg and 5 mg, of Astellas Pharm US, Inc.

According to IQVIA, sales data for the 12 month period ending September 2020, the Prograf Capsules, 0.5 mg, 1 mg and 5 mg market2 achieved annual sales of approximately $286.8 million.

Glenmark’s current portfolio consists of 166 products authorised for distribution in the US marketplace and 45 ANDA’s pending approval with the US FDA.

ANDA approvalGlenmark PharmaTacrolimus CapsulesUS FDA
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