USFDA issues EIR for Piramal Pharma Bethlehem facility
Mumbai: Piramal Pharma has announced that the United States Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (EIR) for the Bethlehem, USA manufacturing facility. The inspection has now been successfully closed by the US FDA.
Piramal Pharma had inspected the facility from 18th September 2023 to 27th September 2023 and issued two observations for the said facility.
Read also: Piramal Pharma gets 2 USFDA observations for Bethlehem 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.
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