On 14 January 2023, the pharma company said that the United States Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and good manufacturing practices (GMP) inspection of its Sellersville (USA) facility from 19 December 2022 to 13 January 2023.
At the conclusion of the inspection, the USFDA issued a Form-483, with two observations. The observations were classified under VAI (Voluntary Action Indicated) and does not relate to data integrity.
Meanwhile, the USFDA has now issued an EIR for the said manufacturing facility and closed the inspection of the same unit.
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 pharmaceutical company reported a consolidated net loss of Rs 90 crore in Q3 December 2022 as against a net profit of Rs 163.37 crore in the year-ago period. Revenue from operations rose by 11% year-on-year to Rs 1,716 crore in Q3 FY23 from Rs 1,539 crore in the year-ago period.
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