-- Piramal Pharma (NSE:PPLPHARMA, BOM:543635) has received the establishment inspection report (EIR) with 'voluntary action indicated' classification from the U.S. Food and Drug Administration (US FDA) for its manufacturing facility in Lexington, India, according to a Monday filing to the Indian stock exchanges.
The FDA conducted a general good manufacturing practices (GMP) inspection of the Lexington facility from Dec. 3, 2025, to Dec. 10, 2025. At the conclusion of the inspection, the US FDA issued a Form-483, with four observations.
The receipt of EIR marks the successful closure of the US FDA's inspection at Piramal Pharma's manufacturing unit in Lexington.
The company's shares were up nearly 1% in recent trade.