Wednesday, June 25, 2025

Piramal Pharma’s Mumbai facility gets 6 observations from US FDA inspection

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Pharmaceutical firm Piramal Pharma Ltd on Tuesday (February 18) announced that the US FDA conducted a general GMP (Good Manufacturing Practice) inspection at its Turbhe, Navi Mumbai, facility between February 11-17, 2025. The inspection concluded with a Form 483 issued, containing six observations.

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“This is to inform you that the US FDA conducted a General GMP inspection at Piramal Pharma Limited’s Turbhe facility from 11th February 2025 to 17th February 2025. On conclusion of the inspection, a Form-483 was issued with 6 observations,” Piramal Pharma said in a regulatory filing.

The company stated that the observations primarily pertain to procedural improvements and are not related to data integrity. Piramal Pharma is preparing a detailed response and plans to submit it within the stipulated timeline.

Also Read: Piramal Pharma shares surge 20% after management guides for doubling revenue by FY30“Observations are largely around improvement of procedures and practices and not related to data integrity. The Company is preparing a detailed response to said observations, which will be submitted to the agency within stipulated timelines,” it said.

The company reaffirmed its commitment to maintaining high compliance standards and expressed confidence in addressing the observations effectively.How Piramal Pharma did in Q3FY25

Piramal Pharma reported a 63.4% year-on-year (YoY) decline in net profit at ₹3.7 crore for the third quarter that ended December 31, 2024. In the corresponding quarter of the previous fiscal, Piramal Pharma posted a net profit of ₹10.1 crore.

Also Read: Nandini Piramal details 5-year growth strategy, expects strong profit growth this year

The company’s revenue from operations increased 12.5% to ₹2,204.2 crore against ₹1,958.6 crore in the year-ago period. At the operating level, EBITDA surged 25.8% to ₹337.7 crore in the third quarter of this fiscal over ₹268.4 crore in Q3FY24.

Shares of Piramal Pharma Ltd ended at ₹196.70, down by ₹3.15, or 1.58%, on the BSE.

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