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The USFDA conducted a pre-approval inspection (PAI) and good manufacturing practices (GMP) inspection of Piramal Pharma's Lexington facility, Kentucky, USA from 27 December 2022 to 10 January 2023.
The observations were classified under voluntary action indicated (VAI) and does not relate to data integrity, the company said.
The company added that it is preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines.
Piramal Pharma lastly added that it remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.
Piramal Pharma is a pharmaceutical company that manufactures and develops a wide range of pharmaceutical solutions to reduce diseases. Piramal Pharma serves customers worldwide.
The company reported a net loss of Rs 37.34 crore in Q2 FY23 as against a net profit of Rs 36.56 crore in Q2 FY22. Net Sales rose 9% YoY to Rs 1,720.01 crore in the quarter ended 30 September 2022.
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