USFDA successfully concludes inspection at Piramal Pharma Ahmedabad facility

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-07-15 06:00 GMT | Update On 2024-07-16 14:49 GMT

Mumbai: Piramal Pharma has announced that the US Food and Drug Administration (US FDA) has successfully concluded a Pre-Approval Inspection ('PAI') with Zero Form - 483 observations and No Action Indicated (NAI) designation at the Company's PPDS Ahmedabad facility.

The inspection was conducted from 10th July 2024 to 12th July, 2024.

"Successful completion of this wholistic inspection at PPDS Ahmedabad facility, will now enable access to our high-end analytical capabilities to our customers for their clinical and commercial batches from an FDA approved site. The Company remains committed to maintain the highest standards of compliance," the Company stated in a BSE filing.

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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USFDA successfully concludes inspection at Piramal Pharma Ahmedabad facility

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