Piramal Pharma Ltd gets 6 observations from USFDA for Lexington facility

Piramal Pharma Limited has announced that the US FDA conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's Lexington (Kentucky, USA) facility from 27th December 2022 to 10th January, 2023.

At the conclusion of the inspection, the US FDA issued a Form-483, with six observations. The observations were classified under VAI (Voluntary Action Indicated) and does not 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. The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.

Shares of Piramal Pharma Limited was last trading in BSE at Rs. 119.00 as compared to the previous close of Rs. 116.80. The total number of shares traded during the day was 270182 in over 2910 trades.

The stock hit an intraday high of Rs. 120.55 and intraday low of 116.40. The net turnover during the day was Rs. 32152141.00.

Source : Equity Bulls

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PiramalPharma PPLPHARMA INE0DK501011 Pharmaceuticals USFDA Form483