Piramal Pharma Lexington facility successfully completes USFDA Inspection
Mumbai: Piramal Pharma Limited has informed in a recent BSE filing that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the manufacturing facility located at Lexington, USA and the Pre-Approval Inspection (PAI) has now been successfully closed by the US FDA.
US FDA had inspected the facility from 20th February, 2024 to 23rd February, 2024 and issued 2 observations.
Read also: Piramal Pharma gets 2 USFDA observations for Lexington facility
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.
Read also: USFDA successfully concludes inspection at Piramal Pharma USA facility
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