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.