Zydus Unit 9 Clears USFDA Pre-Approval Inspection at Changodar Facility
Ahmedabad: Zydus Lifesciences Limited has successfully cleared a Pre-Approval Inspection (PAI) conducted by the U.S. Food and Drug Administration (USFDA) at its injectable medical devices manufacturing facility in Ahmedabad.
The inspection was carried out at the company’s Unit 9 facility located at Zydus Biotech Park, Changodar, from February 16 to 19, 2026.
According to the company’s regulatory filing, the inspection concluded with nil observations, indicating that no Form 483 observations were issued by the USFDA at the close of the inspection.
The development was disclosed under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and has been communicated to stock exchanges.
A clean PAI outcome is considered significant for pharmaceutical and medical device manufacturers, as it indicates regulatory compliance of the facility with current Good Manufacturing Practices (cGMP) and supports product approval processes in the United States.
The Unit 9 facility at Zydus Biotech Park is engaged in the manufacturing of injectable medical devices, catering to regulated markets including the US.
