Industry

USFDA issues EIR For Piramal Pharma Bethlehem Facility

PPS plays a pivotal role in providing end-to-end development and manufacturing solutions to both innovators and generic companies.

The Health Master

November 10, 2023

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Last Updated on October 12, 2024 by The Health Master

EIR

EIR: In a significant stride towards pharmaceutical excellence, Piramal Pharma has recently announced the successful closure of the USFDA inspection at its Bethlehem, USA manufacturing facility.

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This development marks a crucial milestone for the company, highlighting its commitment to maintaining high-quality standards and compliance with regulatory requirements.

Piramal Pharma’s Bethlehem Facility Inspection

From the 18th to the 27th of September 2023, the USFDA conducted an inspection at Piramal Pharma’s manufacturing facility in Bethlehem, USA.

The inspection, which included a thorough assessment of the facility’s operations, has now been successfully concluded by the USFDA.

During the inspection, the USFDA issued two observations, which Piramal Pharma will undoubtedly address with diligence and precision.

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Portfolio and Global Presence of Piramal Pharma Limited

Piramal Pharma Limited (PPL) stands as a global player in the pharmaceutical industry, offering a diverse portfolio of products and services.

With end-to-end manufacturing capabilities spread across 15 global facilities, PPL boasts a robust global distribution network, reaching over 100 countries.

PPL’s Business Segments

PPL operates through various business segments, including Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), specializing in complex hospital generics; and the India Consumer Healthcare business, selling over-the-counter products.

Piramal Pharma Solutions (PPS) Offerings

PPS plays a pivotal role in providing end-to-end development and manufacturing solutions to both innovators and generic companies.

The global network of facilities ensures a seamless approach throughout the drug life cycle, reinforcing Piramal Pharma’s commitment to excellence.

Piramal Critical Care (PCC) Portfolio

PCC’s portfolio includes a range of complex hospital products such as inhalation anaesthetics, intrathecal therapies for spasticity and pain management, injectable pain and anaesthetics, injectable anti-infectives, and other essential therapies.

This diverse portfolio underlines Piramal Pharma’s dedication to meeting critical healthcare needs.

Joint Venture with Allergan

Noteworthy is Piramal Pharma’s joint venture with Allergan, a key player in the pharmaceutical industry.

Additionally, in October 2020, the company received a growth equity investment from the Carlyle Group, further solidifying its position in the market.

Significance of USFDA’s Establishment Inspection Report (EIR)

The issuance of the Establishment Inspection Report (EIR) by the USFDA holds immense significance in the pharmaceutical landscape.

It reflects not only Piramal Pharma’s adherence to regulatory standards but also instills confidence in the company’s stakeholders and the wider pharmaceutical community.

Global Impact and Distribution Network

The USFDA approval for Piramal Pharma’s Bethlehem facility not only signifies a local achievement but also enhances the company’s global impact.

The extensive distribution network spanning over 100 countries further amplifies Piramal Pharma’s reach, ensuring the availability of its products on a global scale.

PPL’s Commitment to Quality and Compliance

Piramal Pharma’s success with the USFDA approval underscores its unwavering commitment to maintaining the highest quality standards and complying with global regulatory requirements.

This commitment forms the foundation of Piramal Pharma’s reputation for reliability and excellence in the pharmaceutical sector.

Future Prospects and Developments

Looking ahead, Piramal Pharma is poised for continued success and growth.

The positive outcome of the USFDA inspection sets the stage for future projects and developments, further solidifying Piramal Pharma’s position as a key player in the pharmaceutical industry.

FAQs

What is the significance of the USFDA’s Establishment Inspection Report (EIR)?
- The EIR holds immense importance as it reflects a pharmaceutical company’s adherence to regulatory standards, ensuring quality and compliance.
How does Piramal Pharma’s global distribution network contribute to its success?
- The extensive distribution network in over 100 countries enhances Piramal Pharma’s global impact, making its products accessible on a wider scale.
What are the key offerings of Piramal Pharma Solutions (PPS)?
- PPS provides end-to-end development and manufacturing solutions, serving both innovators and generic companies throughout the drug life cycle.
Can you elaborate on Piramal Critical Care’s (PCC) complex hospital product portfolio?
- PCC’s portfolio includes inhalation anaesthetics, intrathecal therapies, injectable pain and anaesthetics, injectable anti-infectives, and other essential therapies.
How does Piramal Pharma’s joint venture with Allergan impact its business?
- The joint venture with Allergan, coupled with a growth equity investment from the Carlyle Group, strengthens Piramal Pharma’s position and capabilities in the pharmaceutical sector.

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