Piramal Pharma's USA facility gets 3 observations from USFDA

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.

Powered by Capital Market - Live News