Zydus Gets USFDA Nod for Plant

  Published 10 months ago

USFDA cleared Zydus’ Gujarat plant after a smooth remote audit for Atorvastatin tablets’ Prior Approval Supplement submission.

  • Remote Regulatory Assessment at Matoda site completed without any observations, signaling strong compliance standards.
  • Plant recommended for approval for Atorvastatin Calcium Tablets in 10 mg, 20 mg, 40 mg, and 80 mg strengths.
  • Approval supports Zydus’ expansion in US generics market, reinforcing manufacturing quality and regulatory adherence.
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