Piramal Pharma Solutions Achieves Updated GMP Certificates
Piramal Pharma Solutions, a prominent global Contract Development and Manufacturing Organization (CDMO), is thrilled to announce the receipt of updated MHRA GMP certificates for its facility located in Grangemouth, UK. This advancement marks a significant milestone in the company's commitment to quality and compliance in the pharmaceutical industry.
Certificates Overview
The updated certificates effectively cover all activities performed within the Helix building of the Grangemouth facility. This includes its supporting warehouse and laboratory areas, critical for the clinical and commercial production of drug substances. The achievement follows the submission of a meticulous MHRA GMP compliance report and a successful desktop inspection process.
Focus on Quality
With these updated GMP certificates valid for a duration of three years, the Grangemouth facility is poised to ensure that it meets rigorous operational standards. Piramal Pharma Solutions takes great pride in its exceptional regulatory history, having maintained a remarkable record across numerous respected authorities such as the USFDA, PMDA, ANVISA, and others.
Support for Drug Development Programs
Piramal Pharma Solutions' Grangemouth site is not just another facility; it plays an integral role in the company's antibody-drug conjugate (ADC) development and manufacturing endeavors. By providing comprehensive solutions for bioconjugates—from initial process development to scale-up—the facility is central to the ADCelerate™ program. This program is designed to enhance pathways from research to GMP production, aiming to expedite lifesaving therapies to patients.
CEO's Insight
Peter DeYoung, the CEO of Piramal Global Pharma, expressed pride in this achievement: "This accomplishment highlights our dedication to maintaining the highest standards of quality across our operations. These updated MHRA GMP certificates allow us to continue supporting our partners in drug development, ensuring timely access to advanced therapies for those in need."
About Piramal Pharma Solutions
Piramal Pharma Solutions (PPS) is a prominent player in the CDMO landscape, offering a comprehensive suite of development and manufacturing services across the entire drug life cycle. Its global integration spans facilities across North America, Europe, and Asia, enabling PPS to provide diverse services, including drug discovery, clinical trial supplies, and commercial API supply. Specialized services are also available for highly potent APIs, antibody-drug conjugations, sterile fill/finish, and other complex pharmaceutical needs.
About Piramal Pharma Limited
Piramal Pharma Limited (PPL) is recognized for its innovative products and services, operating through a network of 17 global facilities and a wide distribution network that reaches over 100 countries. The portfolio includes a mix of businesses, such as Piramal Pharma Solutions, Piramal Critical Care, and Piramal Consumer Healthcare, advancing their position in the competitive pharmaceutical market. Through strategic investments, like the one in Yapan Bio Private Limited, PPL also ventures into biologics and vaccines, underscoring their commitment to diverse healthcare solutions.
Frequently Asked Questions
What are the new GMP certificates for?
The updated GMP certificates indicate compliance with stringent manufacturing standards in the pharmaceutical industry, enhancing service delivery at Piramal's Grangemouth facility.
How often are GMP certificates updated?
GMP certificates are generally reviewed and renewed every three years, following rigorous assessments to ensure compliance with regulatory standards.
What does Piramal's ADC facility specialize in?
The Grangemouth facility specializes in the development and manufacturing of antibody-drug conjugates (ADCs), supporting the development of complex bioconjugate therapies.
Is Piramal expanding its services?
Yes, Piramal Pharma Solutions is continuously enhancing its service offerings to adapt to evolving market needs, including expanding its role in biologics and life sciences.
What is the ADCelerate™ program?
The ADCelerate™ program is an initiative at Piramal that streamlines the transition from research to GMP production of ADC therapies, helping bring innovative treatments to patients faster.
