Piramal Pharma Turbhe facility gets USFDA EIR
Mumbai: Piramal Pharma has informed in a BSE filing that the US Food and Drug and Administration (USFDA) has issued an Establishment Inspection Report (EIR) for the company's Turbhe facility with VAI (Voluntary Action Indicated).
Receipt of said EIR marks successful closure of the Good Manufacturing Practices (GMP) inspection.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
The facility was inspected from 11th February, 2025 to 17th February, 2025. The facility initially received six observations.
Read also: USFDA issues 6 observations for Piramal Pharma Turbhe facility
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 Pharma begins Sevoflurane commercial production at Digwal facility
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