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Pharmaceuticals
USFDA11 May 2024, 07:37 pm

Zydus Lifesciences Receives Final USFDA Approval for Dexamethasone Tablets USP, 1 mg

AI Summary

Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to market Dexamethasone Tablets USP, 1 mg in the United States. The product will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh. Dexamethasone Tablets USP, 1 mg had annual sales of USD 1.8 mn in the United States in the previous year. With this approval, Zydus now has a total of 395 approvals and has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.

Key Highlights

  • Zydus Lifesciences Limited receives final approval from USFDA for Dexamethasone Tablets USP, 1 mg
  • The product will be manufactured at the group's formulation manufacturing facility at Baddi, Himachal Pradesh
  • Dexamethasone Tablets USP, 1 mg had annual sales of USD 1.8 mn in the United States
  • This is the 395th approval for Zydus Lifesciences
  • Zydus has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04
ZYDUSLIFE
Pharmaceuticals
Zydus Lifesciences Ltd

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