USFDA Inspection: Successfully Concluded at Piramal Pharma

Overall, the positive USFDA inspection report for the Riverview facility marks a significant milestone for Piramal Pharma Limited

The Health Master

April 19, 2024

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Last Updated on December 22, 2024 by The Health Master

USFDA Inspection

Piramal Pharma Limited (PPL) recently announced a significant win for its US operations after the USFDA Inspection.

The US Food and Drug Administration (USFDA) has issued a successful Establishment Inspection Report (EIR) for their Riverview, USA manufacturing facility.

This positive outcome signifies that the facility meets the USFDA’s stringent quality standards for pharmaceutical manufacturing.

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Prior Inspection with Observations Successfully Addressed

Earlier reports indicated that the USFDA conducted a Pre-Approval Inspection (PAI) at the Riverview facility in February 2024.

While the USFDA inspection resulted in three observations, these were classified under Voluntary Action Indicated (VAI), suggesting they didn’t pose major compliance risks.

PPL effectively addressed these observations, paving the way for a successful closure of the USFDA inspection.

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About Piramal Pharma Limited

Piramal Pharma Limited (PPL) is a leading pharmaceutical company with a global presence.

They offer a comprehensive portfolio of differentiated products and services, supported by a robust infrastructure.

Here’s a closer look at PPL’s key strengths:

End-to-End Manufacturing Capabilities:

PPL operates 15 global facilities equipped for comprehensive manufacturing, providing a one-stop solution for pharmaceutical companies.

Global Distribution Network:

PPL’s extensive network reaches over 100 countries, ensuring efficient delivery of their products to a vast customer base.

Diversified Business Units:

PPL operates under three distinct business units:

Piramal Pharma Solutions (PPS): A leading Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions for innovators and generic companies.
Piramal Critical Care (PCC): Focuses on complex hospital generics, including products like inhalation anesthetics, pain management solutions, and anti-infectives.
India Consumer Healthcare: Caters to the Indian market with a portfolio of over-the-counter healthcare products.

Strategic Partnerships:

PPL leverages strategic collaborations to further enhance its reach.

They have a joint venture with Allergan, a prominent pharmaceutical company. Additionally, the Carlyle Group, a renowned investment firm, provided PPL with growth equity in October 2020.

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Positive Implications for PPL

The successful USFDA inspection report for the Riverview facility signifies a significant achievement for PPL. This positive outcome translates to several benefits:

Enhanced Market Access:

The USFDA’s approval opens doors for PPL to expand its reach in the lucrative US market.

They can now manufacture and distribute a wider range of products within the US, catering to a larger customer base.

Strengthened Reputation:

Receiving a clean bill of health from the USFDA reinforces PPL’s commitment to quality and compliance.

This bolsters their reputation as a reliable and trustworthy pharmaceutical manufacturer.

Investor Confidence:

The successful USFDA inspection report is likely to be well-received by investors, potentially boosting PPL’s stock value and attracting further investment.

Overall, the positive USFDA inspection report for the Riverview facility marks a significant milestone for Piramal Pharma Limited.

This achievement strengthens their position in the global pharmaceutical market and paves the way for future growth in the crucial US market.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.