Mumbai: Piramal Pharma has recently announced that the US Food and Drug Administration (USFDA) has successfully concluded the inspection of the company’s manufacturing facility located at Sellersville, USA and has issued an Establishment Inspection Report (EIR) for the said facility. EIR is the final inspection report of an FDA inspection.
The inspection was held between December 19, 2022 and January 13, 2023.
“This is to inform you that US FDA has issued an Establishment Inspection Report (EIR) for the Sellersville, USA manufacturing facility and the inspection has now been successfully closed by the US FDA,” the company informed in a BSE filing.
The company’s Sellersville, USA facility is a fully integrated site that offers product and process development, clinical supply and commercial manufacturing and packaging of solid oral dosage forms, liquids, creams, and ointments.
Piramal Pharma Limited (PPL) offers a portfolio of differentiated 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; Piramal Critical Care (PCC), a Complex Hospital Generics business, and the India Consumer Healthcare business selling over-the-counter products.
PPS offers end-to-end development and manufacturing solutions through a globally integrated network of facilities across the drug life cycle to innovators and generic companies. PCC’s complex hospital product portfolio includes inhalation anaesthetics, intrathecal therapies for spasticity and pain management, injectable pain and anaesthetics, injectable anti-infectives, and other therapies. In addition, PPL has a joint venture with Allergan. In October 2020, the company received a growth equity investment from the Carlyle Group.