Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organization (CDMO) and part of Piramal Pharma Ltd., has announced that its Grangemouth facility in the UK has received updated Good Manufacturing Practice (GMP) certificates from the Medicines and Healthcare products Regulatory Agency (MHRA). The update follows a successful compliance report and desktop inspection.

The new certificates cover all activities within the facility’s Helix building, which focuses on clinical and commercial drug substance manufacturing and testing. They also include supporting warehouse and laboratory areas. Combined with the site's existing GMP certificates, the updated certificates further strengthen Grangemouth’s capabilities to support client programmes and regulatory filings.

The Grangemouth site serves as Piramal Pharma Solutions’ dedicated antibody–drug conjugate (ADC) development and manufacturing facility, offering comprehensive solutions for bioconjugates, from process development to scale-up. The site also plays a critical role in the ADCelerate programme, designed to streamline the path from R&D to GMP production and accelerate the delivery of bioconjugate therapies to clinical settings.  

Piramal highlighted that the updated MHRA certifications reinforce the site’s longstanding reputation for regulatory excellence, backed by a history of successful inspections from major global agencies including 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,” he added.  

The updated certificates are valid for three years.