Piramal Pharma Limited (PPL) has informed that USFDA conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection of Piramal Pharma Limited's Sellersville (USA) facility from 19th December 2022 to 13th 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 do not relate to data integrity.

The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines. The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations.

Piramal Group is a global business conglomerate with diverse interests in pharma, financial services and real estate. The Group has offices in over 30 countries and a global brand presence in more than 100 markets, and operates with over 10,000 people worldwide from 21 diverse nationalities.

In over three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group has strived for inclusive growth, while adhering to ethical and values-driven practices.

Piramal Pharma Limited offers a diverse range of products and services through end-to-end manufacturing capabilities across 15 global facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization (CDMO), Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.