Piramal Pharma gets 2 USFDA observations for Bethlehem facility
Mumbai: Piramal Pharma has announced that the US Food and Drug Administration (USFDA) has concluded a Good Manufacturing Practices (GMP) Inspection with two observations at the Company's Bethlehem facility.
The inspection was held from 18th September 2023 to 27th September 2023.
"On conclusion of the inspection, a Form-483 was issued with 2 observations," the Company informed in a BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Both observations relate to system improvement only, and none are related to data integrity.
"The Company is preparing a detailed response to said observations, which will be submitted to the US FDA within stipulated timelines. The Company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all observations," Piramal stated.
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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