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Biocon Pharma Limited Secures U.S. FDA Tentative Approval for Sitagliptin Tablets

  • Tue, 26-Aug-2025
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

This is to inform you that Biocon Pharma Limited, a wholly-owned subsidiary of the Company, has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its ANDA for Sitagliptin Tablets USP, in 25 mg, 50 mg and 100 mg strengths. Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The approval will further strengthen Biocon’s portfolio of vertically integrated drug products.


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Author: BIOCON

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