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The U.S. Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma's Lexington (Kentucky, USA) facility from 27 December 2022 to 10 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 did not relate to data integrity.
Meanwhile, USFDA has now issued an Establishment Inspection Report (EIR) to the said manufacturing facility and the inspection has now been successfully closed by the US FDA.
Piramal Pharma (PPL) reported 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 Q3FY23 from Rs 1,539 crore in the year-ago period.
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. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.
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