#United Kingdom #Piramal Pharma #Grangemouth #MHRA GMP

Piramal Pharma Solutions Achieves MHRA GMP Certification

In a significant achievement in the pharmaceutical sector, Piramal Pharma Solutions has announced that its Bioconjugate Facility located in Grangemouth, UK, has been awarded updated MHRA GMP certifications. These certifications are critical for ensuring that the facility meets the highest standards of manufacturing practices in the production of pharmaceuticals, particularly in the field of bioconjugates.

The updated MHRA GMP certificates apply to all activities undertaken at the Helix building of the Grangemouth site, including its various storage and laboratory areas. This certification comes after the successful submission of a compliance report to the MHRA and a thorough desktop inspection. Valid for three years, the new certificates reaffirm the company's commitment to quality and regulatory compliance in its manufacturing processes.

Peter DeYoung, CEO of Piramal Global Pharma, expressed satisfaction regarding this significant milestone, stating, "This achievement highlights our Grangemouth site's dedication to adhering to the highest quality standards across all areas of operation. With these updated MHRA GMP certifications, we can continue to support our partners in drug development effectively and deliver critical bioconjugate therapies to patients with precision and reliability."

The Grangemouth facility serves as a specialized development and manufacturing site for Antibody-Drug Conjugates (ADCs), which are vital for advancing treatments for various cancers. The facility not only engages in process development but also offers comprehensive solutions that extend to the scaling of bioconjugates. Additionally, the site plays a significant role in the ADCelerate™ program, which is designed to streamline the transition from research and development to commercial manufacturing, thus facilitating faster availability of life-saving therapies to clinics.

Moreover, the continued partnership with regulatory bodies like the MHRA, along with certifications from the FDA, PMDA, ANVISA, and other international health organizations, reflects Piramal's robust track record in maintaining compliance and a successful history of inspections. This instrumental achievement enables the Grangemouth facility to be well-prepared for supporting the programs and submission applications of its clients.

Piramal Pharma Solutions operates as a Contract Development and Manufacturing Organization (CDMO) providing end-to-end pharmaceutical development and manufacturing solutions. With a global network integrating facilities in North America, Europe, and Asia, the company aims to offer a full range of services including drug research, pharmaceutical development, clinical trial accessories, and commercial delivery of Active Pharmaceutical Ingredients (APIs) as well as finished dosage forms.

The company also focuses on specialized services such as the manufacture of highly active APIs, sterile filling, and the production of effective solid oral dosages. In addition to its existing capabilities, Piramal Pharma Solutions invests in areas like biologics, vaccines, gene therapies, and monoclonal antibodies, through partnerships and collaborative initiatives, including its strategic investment in Yapan Bio Private Limited.

The newly awarded MHRA GMP certifications serve as a testament to the dedication of Piramal Pharma Solutions in advancing pharmaceutical excellence and ensuring that the highest quality of bioconjugate therapies continues to reach those in need. This development not only reinforces the site’s operational capabilities but also enhances its reputation in the competitive pharmaceutical landscape.

For further updates and insights into Piramal Pharma Solutions, including detailed information about its product offerings and services, visit their official website and follow them on their social platforms.