USFDA issues EIR for Piramal Pharma Ahmedabad facility

Mumbai: Piramal Pharma has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its manufacturing facility in Ahmedabad, India.

This follows an inspection conducted from July 10 to July 12, 2024, which concluded with zero Form 483 observations and a No Action Indicated (NAI) designation.

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. 

Read also: USFDA successfully concludes inspection at Piramal Pharma Ahmedabad facility

According to the BSE filing, the issuance of the EIR signifies the formal closure of the inspection.

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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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