Disclosure under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 - US FDA Inspection at Aurora facility
Awaiting price reaction for this filing.
The US FDA conducted a general Good Manufacturing Practices (GMP) inspection at Piramal Pharma's Aurora, Canada facility from May 26 to May 30, 2025. The inspection was completed successfully with Zero Form-483 observations and a No Action Indicated (NAI) designation, which is the best possible outcome. This indicates that the facility meets US FDA's quality and compliance standards with no deficiencies flagged. The company has highlighted its commitment to maintaining the highest standards of compliance.
Positive for shareholders — a clean US FDA inspection with NAI designation removes regulatory uncertainty for the Aurora facility and reinforces confidence in the company's manufacturing quality, which supports its ability to serve the important US market without disruption.