Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., is pleased to announce that its Grangemouth, UK facility has received updated MHRA GMP certificates following a successful compliance report and desktop inspection.

These certificates encompass all activities within the facility’s Helix building, which specializes in clinical and commercial drug substance manufacture and testing. They also extend to the building’s supporting warehouse and laboratory areas. Together with the site’s existing GMP certificates, the updated certificates ensure Grangemouth is well-equipped to support its clients’ programs and regulatory filings.

As Piramal Pharma Solutions’ dedicated antibody-drug conjugate (ADC) development and manufacturing facility, Grangemouth offers comprehensive solutions for bioconjugates, from process development to scale-up. The site also plays a critical role in the ADCelerate™ program, which streamlines the path from R&D to GMP production to bring lifesaving bioconjugate therapies to patients in the clinic faster.

The updated MHRA GMP certificates reflect an ongoing commitment to excellence at Grangemouth, as evidenced by an exceptional regulatory track record and a longstanding history of successful inspections by the USFDA, PMDA, ANVISA, the Turkish Ministry of Health, and the South Korean FDA.

“This achievement underscores the Grangemouth facility’s dedication to upholding the highest standards of quality across their operations,” said Peter DeYoung, CEO, Piramal Global Pharma. “With these updated MHRA GMP certificates, the site can continue supporting our partners in this critical area of drug development, helping them bring bioconjugate therapies to patients in need with the utmost precision, efficiency, and reliability.”