At the end of the review, the US FDA issued a Form 483 with four observations. These relate to enhancements in procedures and are expected to be classified as VAI, or voluntary action indicated.
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Shares of Piramal Pharma will be in focus on Friday, December 12, after the US Food and Drug Administration completed a general Good Manufacturing Practices inspection of the company’s Lexington facility in Kentucky.
The inspection was carried out between December 3 and December 10, 2025.
At the end of the review, the US FDA issued a Form 483 with four observations. These relate to enhancements in procedures and are expected to be classified as VAI, or voluntary action indicated.
Piramal Pharma said it is preparing a detailed response that will be submitted to the agency within the stipulated timelines. The company added that it remains committed to maintaining the highest standards of compliance and will work closely with the regulator to address all observations.
Piramal Pharma shares closed 0.65% higher on Thursday at ₹172.10. The stock is down 33% so far in 2025.
First Published: Dec 12, 2025 7:25 AM IS
