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Pharmaceuticals
USFDA6 Apr 2024, 07:46 pm

Gland Pharma Limited Receives US FDA Approval for Eribulin Mesylate Injection - First Generic on Market, Expects Near-Term Launch

AI Summary

Gland Pharma Limited, a leading injectable-focused pharmaceutical company, has announced the US Food and Drug Administration (FDA) approval for its Eribulin Mesylate Injection, 0.5 mg/mL Single Dose Vial, making it the first generic approval in the market. The Company is set to launch this product through its marketing partner soon. With US sales of approximately USD 92 million for the twelve months ending in February 2024, as per IQVIA, this product is anticipated to contribute significantly. Gland Pharma, established in Hyderabad in 1978, is a global player with a wide range of injectables and an excellent track record in development, manufacturing, and marketing of sterile injectables.

Key Highlights

  • Gland Pharma Limited receives US FDA approval for Eribulin Mesylate Injection
  • First generic approval in the market
  • Expected launch in the near term
  • Product has US sales of approximately USD 92 million
  • Company is a global player with a wide range of injectables and an excellent track record in development, manufacturing, and marketing of sterile injectables
GLAND
Pharmaceuticals
Gland Pharma Ltd

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