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Biocon Pharma Limited Receives U.S. FDA Approval for Tofacitinib Extended-Release Tablets

  • Wed, 19-Nov-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 approval from the U.S Food and Drug Administration (U.S. FDA) for its ANDA for Tofacitinib Extended Release Tablets. Final approval received for 11mg strength and tentative approval for 22mg strength. Tofacitinib extended-release tablets are a Janus kinase (JAK) inhibitor indicated for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Ulcerative Colitis.

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


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Author: BIOCON

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