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Piramal Pharma's Lexington facility receives four USFDA observations
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(12:24, 12 Dec 2025)
The inspection took place from 3 to 10 December 2025. At the end of the inspection, the US FDA issued a Form 483 with four observations, which relate to procedural enhancements and are expected to be categorized as VAI (Voluntary Action Indicated).

The company is preparing a detailed response to be submitted within the stipulated timelines and said it remains committed to the highest standards of compliance, working closely with the regulator to address all points raised.

Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products.

The company reported a consolidated net loss of Rs 99.22 crore in Q2 FY26, compared with a net profit of Rs 22.59 crore recorded in Q2 FY25. Revenue from operations for the period under review declined 8.83% year-on-year (YoY) to Rs 2,043.72 crore.

Shares of Piramal Pharma rose 0.93% to Rs 173.40 on the BSE.

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