USFDA successfully concludes inspection at Piramal Pharma USA facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-04-18 12:06 GMT   |   Update On 2024-04-18 12:06 GMT
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Mumbai: Piramal Pharma Limited has informed through a recent BSE filing that the US Food and Drug ADministration (US FDA) has issued an Establishment Inspection Report (EIR) for the Riverview, USA manufacturing facility and the inspection has now been successfully closed by the US FDA.

Medical Dialogues team had earlier reported that the US FDA had concluded a Pre-Approval Inspection (PAI) with 3 observations at the Company's Riverview (USA) facility.

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Read also: Piramal Pharma gets 3 USFDA observations for US 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.

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: Piramal Critical Care unveils new 10mg/10mL (1 mg/mL) concentration of Zinc Sulfate for Injection in US

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