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Biocon Pharma Limited Receives U.S. FDA Approval for ANDA of Everolimus Tablets

  • Thu, 10-Apr-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 Biocon Limited, has received approval for its ANDA for Everolimus Tablets from the US FDA, in strengths of 0.25 mg, 0.5 mg, 0.75 mg, and 1 mg. Everolimus is a prescription medication that is indicated for the prophylaxis of organ rejection in adult patients, and in kidney and liver transplantation.

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


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Author: BIOCON

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