Piramal Pharma Solutions (PPS), a global CDMO player, has announced that its Grangemouth facility has earned updated MHRA GMP certification after a successful compliance review. 

The certification is an official nod from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) that confirms a pharma facility complies with Good Manufacturing Practice (GMP) standards. 

The certification, the pharma giant said, covers all operations in the Helix building, including drug substance manufacturing, testing, and supporting labs and warehouses, strengthening the site’s ability to support clients’ programs and regulatory filings worldwide. 

Grangemouth serves as PPS’s dedicated antibody-drug conjugate (ADC) development and manufacturing hub, offering end-to-end solutions from process development to scale-up. The site is central to the ADCelerate program, designed to accelerate the journey from R&D to GMP production, bringing lifesaving bioconjugate therapies to patients faster. 

“This achievement underscores Grangemouth’s unwavering commitment to quality and regulatory excellence,” said Peter DeYoung, CEO, Piramal Global Pharma. “With these updated MHRA GMP certificates, the facility is even better positioned to help partners deliver bioconjugate therapies with precision, efficiency, and reliability.” 

The Grangemouth site boasts a proven regulatory track record, including successful inspections by the US FDA, PMDA, ANVISA, the Turkish Ministry of Health, and the South Korean FDA, reflecting PPS’s ongoing dedication to operational excellence. 

Piramal Pharma Solutions is a global CDMO offering comprehensive development and manufacturing services across the drug lifecycle.