USFDA successfully completes inspection at Piramal Pharma Canada facility
ADH Under Fire After Inspection
Mumbai: Piramal Pharma Limited has announced that the US Food and Drug Administration (USFDA) has successfully completed inspection at the company's facility at Aurora, Canada with Zero Form-483 observations and No Action Indicated (NAI) designation.
NAI means no objectionable conditions or practices were found during the inspection.
"This is to inform that the US FDA conducted a general GMP (Good Manufacturing Practices) Inspection of Piramal Pharma Limited's facility at Aurora, Canada from 26th May 2025 to 30th May, 2025," the company stated in a BSE filing.
Read also: Piramal Pharma arm, BrePco Biopharma get UKMHRA approval for Neoatricon in UK
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.
"The Company remains committed to maintain the highest standards of compliance," it added.
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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.
Read also: Piramal Pharma arm, BrePco Biopharma get UKMHRA approval for Neoatricon in UK
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