USFDA successfully concludes inspection at Piramal Pharma Pithampur facility
Mumbai: Piramal Pharma Limited has announced that the US Food and Drug Administration (USFDA) has successfully concluded an inspection at the company's Pithampur facility with Zero Form-483 observations.The inspection was held from 15th May 2023 to 19th May, 2023."This is to inform you that the US FDA conducted a Good Manufacturing Practices (GMP) plus Pre-Approval Inspection of Piramal...
Mumbai: Piramal Pharma Limited has announced that the US Food and Drug Administration (USFDA) has successfully concluded an inspection at the company's Pithampur facility with Zero Form-483 observations.
The inspection was held from 15th May 2023 to 19th May, 2023.
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: Piramal Pharma Solutions, Plus Therapeutics expand collaboration for cGMP drug production
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.
Read also: USFDA inspection: Piramal Pharma gets Form 483 with 6 observations for Lexington facility
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