Piramal Pharma Receives Establishment Inspection Report from US FDA for Lexington Facility
Piramal Pharma gets EIR for Lexington facility from US FDA
Business Standard
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Piramal Pharma's manufacturing facility in Lexington, Kentucky, received an establishment inspection report from the US FDA, indicating voluntary action required. The inspection, conducted in December 2025, resulted in four observations, which the company is addressing. Despite challenges, Piramal reported a slight increase in stock price.
- 01Piramal Pharma's Lexington facility received an establishment inspection report from the US FDA.
- 02The inspection revealed four observations classified as voluntary action indicated (VAI).
- 03Piramal Pharma is preparing a response to the FDA's observations.
- 04The company reported a consolidated net loss of ₹136.19 crore in Q3 FY26.
- 05Piramal Pharma's stock price increased by 0.68% to ₹147.10 on the BSE.
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Piramal Pharma announced that its manufacturing facility in Lexington, Kentucky, USA, received an establishment inspection report (EIR) from the US Food and Drug Administration (FDA), indicating voluntary action required (VAI). The inspection took place from December 3 to December 10, 2025, and concluded with the issuance of a Form-483, which included four observations related to procedural enhancements. The company is currently preparing a detailed response to these observations to submit to the FDA within the required timelines. Despite facing challenges, including a consolidated net loss of ₹136.19 crore in the quarter ending December 2025 compared to a profit of ₹3.68 crore in the same quarter the previous year, Piramal Pharma's stock rose by 0.68%, trading at ₹147.10 on the Bombay Stock Exchange (BSE).
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The inspection results may affect Piramal Pharma's operational processes and compliance, which could influence future production and market performance.
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