Piramal Pharma Gets Four US FDA Observations at Lexington Plant; Stock Trades Flat

Shares of Piramal Pharma Ltd are trading flat after touching a day’s high of Rs 174.59 on 12th December, as the company said on Thursday (11th December) that the US Food and Drug Administration (US FDA) has issued a Form 483 with four observations following a routine Good Manufacturing Practices (GMP) inspection at its Lexington, Kentucky facility.

The inspection took place between 3rd December and 10th December, 2025, the company said in a regulatory filing.

Piramal Pharma said the observations relate to procedural improvements. These are expected to be classified as VAI (Voluntary Action Indicated), which does not require mandatory regulatory action.

The company is preparing a detailed response that will be submitted to the US FDA within the required timeframe.

Piramal added that it remains committed to high standards of quality and compliance. It will work with the regulator to address the observations fully.

At 11:43 AM, shares of Piramal Pharma were trading 0.15% higher at Rs 172.05 on NSE.

Ready to invest like a pro? Unicorn Signals app equips you with 100+ Free tools and knowledge you need to succeed. Download the Unicorn Signals app and gain access to daily stock lists and insightful market analysis and much more!

The post Piramal Pharma Gets Four US FDA Observations at Lexington Plant; Stock Trades Flat appeared first on Equitypandit.