Piramal Pharma's Sellersville unit gets Form-483 with three observations from US FDA

In a regulatory filing made on Sunday, the company stated that the US FDA had conducted a good manufacturing practices (GMP) inspection of Piramal Pharma?s facility at Sellersville, USA, from 4th May 2026 to 8th May 2026.

At the conclusion of the inspection, US FDA issued a Form-483, with three observations.

At the closing meeting observations were recommended to be classified under VAI (voluntary action indicated) by inspectors. None of the observation relate to data integrity.

The company is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines, Piramal Pharma said in a statement.

Piramal Pharma offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries.

The company a consolidated net loss of Rs 8.83 crore in the quarter ended March 2026 as against net profit of Rs 153.50 crore during the previous quarter ended March 2025. Sales declined 0.08% to Rs 2,751.77 crore in Q4 FY26 as compared with Q4 FY25.

The scrip shed 0.72% to currently trade at Rs 178.45 on the BSE.

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