Piramal Pharma Solutions' Grangemouth Facility Achieves Updated GMP Certifications from MHRA

Piramal Pharma Solutions Achieves Significant Certification Update at Grangemouth Facility

Piramal Pharma Solutions has made remarkable strides by securing updated Good Manufacturing Practice (GMP) certifications from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its Grangemouth manufacturing facility. This achievement comes after a successful compliance report and a thorough inspection process, reaffirming the facility's commitment to maintaining the highest standards in pharmaceutical production.

The updated certificates encompass every aspect of operations within the Helix building, including the warehouse and laboratory facilities. This comprehensive accreditation not only validates the site’s commitment to quality but also strengthens its capacity to support clients' regulatory submissions and clinical programs. The GMP certification is valid for three years, enabling continued support for bioconjugate drug development initiatives.

Located strategically in Grangemouth, Piramal’s facility specializes in the development and clinical testing of drug entities with a focus on bioconjugates. These products are vital in enhancing the effectiveness of cancer therapies by targeting tumor cells specifically, thus maximizing therapeutic outcomes while minimizing side effects.

Peter DeYoung, the CEO of Piramal Global Pharma, emphasizes the significance of this accomplishment: “This success underscores the Grangemouth facility's dedication to meeting the highest quality standards across all activities.” He further noted that the obtained GMP certificates enable the site to sustain its support for partners in this crucial drug development sector, facilitating access to life-saving treatments with utmost precision and reliability.

The Grangemouth facility is pivotal to Piramal’s ADCelerate™ program, which focuses on streamlining the path from research and development to commercial manufacturing of antibody-drug conjugates (ADCs). This initiative aims to expedite the delivery of life-saving therapies to patients, a goal strengthened by the facility’s high regulatory compliance history, which includes successful inspections by the US FDA, PMDA, ANVISA, Turkey's Health Ministry, and Korea’s FDA.

Piramal Pharma Solutions is a leading global Contract Development and Manufacturing Organization (CDMO) that offers end-to-end solutions across the pharmaceutical product lifecycle. The company caters to a myriad of client needs from discovery through to commercial supply across its integrated global network spanning North America, Europe, and Asia.

Moreover, Piramal Pharma's capabilities extend to high-potency active pharmaceutical ingredients (APIs), sterile filling and finishing services, as well as robust solid dosage forms. The organization also excels in the development and manufacturing of biological products, such as vaccines and gene therapies, facilitated through its collaboration with Yapan Bio Private Limited.

Commitment to Excellence

This latest certification update reflects Piramal Pharma Solutions' unwavering commitment to excellence and innovation in the healthcare arena. With a rich history of regulatory success and a focus on maintaining optimal quality standards, the Grangemouth facility stands poised to contribute significantly to advancements in bioconjugate therapies, affirming its role as an essential player in today's pharmaceutical landscape.

For more information on Piramal Pharma Solutions and the innovative services they provide, visit Piramal Pharma Solutions and connect via LinkedIn or Facebook.