Piramal Pharma gets 2 USFDA observations for Lexington facility

Mumbai: Piramal Pharma has announced that the US Food and Drug Administration (US FDA) has concluded a Pre-Approval Inspection (PAI) with 2 observations of the Company’s Lexington (USA) facility for one of the product expected to be manufactured at this facility.

The inspection was conducted from 20th February, 2024 to 23rd February, 2024.
On conclusion of the inspection, a Form-483 was issued with 2 observations. 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
observations does not pose any risk to site’s compliance standards or its business continuity.
The Company is preparing a detailed response to said observations, which will be submitted
to the US FDA within stipulated timelines,” the Company added.
“The Company remains committed to maintain the highest standards of compliance and will
work closely with the agency to comprehensively address all the observations,” Piramal further added.
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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