Piramal Pharma gets 3 USFDA observations for US facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-02-08 05:48 GMT | Update On 2024-03-21 16:00 GMT
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Mumbai: Piramal Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection (PAI) with 3 observations at the Company's Riverview (USA) facility.
The inspection was conducted from 29th January 2024 to 6th February 2024.
"On conclusion of the inspection, a Form-483 was issued with 3 observations," the Company stated in a BSE filing.
The observations were classified under VAI (Voluntary Action Indicated) and does not relate 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 the observations," Piramal said.
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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