USFDA successfully completes inspection at Piramal Pharma Canada facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-06-02 06:30 GMT   |   Update On 2025-06-02 06:30 GMT

USFDA successfully completes inspection at Piramal Pharma Canada facility

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.

The inspection was held from 26th May 2025 to 30th May, 2025.

"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.

Read also: Piramal Pharma begins Sevoflurane commercial production at Digwal facility

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

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News