Piramal Pharma said that US Food and Drug Administration (USFDA) conducted pre approval inspection (PAI) at its Riverview, USA facility.
The USFDA conducted inspection from 29 January to 6 February 2024. On conclusion of the inspection, a Form-483 was issued with 3 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 said observations, which will be submitted to the US FDA within stipulated timelines.
Piramal Pharma (PPL) offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 17 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the-counter products.
The company reported a consolidated net profit of Rs 10.11 crore in Q3 FY24 as compared to a net loss of Rs 90.18 crore posted in Q3 FY23. Revenue from operations grew by 14.14% year on year to Rs 1,958.57 crore during the quarter.
The scrip declined 1.17% to settle at Rs 139.25 on Wednesday, 7 February 2024.
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