MedPharm announces US FDA inspection of North Carolina manufacturing facility
Esme Needham | January 6, 2026 | News story | Manufacturing and Production | FDA, MedPharm
MedPharm has announced that the US Food and Drug Administration (FDA) has completed a successful inspection of its topical drug product manufacturing facility in Durham, North Carolina.
The facility was purpose-built for the manufacture of topical drug products and spans 110,000 square feet. As well as containing clinical and commercial manufacturing systems that meet Current Good Manufacturing Practice (CGMP) standards, the facility is also home to research, drug development and quality assurance. Semi-solid dosage forms are produced at the Durham site.
Bill Humphries, CEO of MedPharm, said: “For our valued clients – who rely on MedPharm for our proven innovation, technical expertise and manufacturing leadership – this achievement further reinforces the strength of our topicals finished dosage manufacturing facility and our dedication to quality, compliance and dependable execution.
“Receiving an FDA inspection outcome with no Form 483 issued and no action indicated (NAI) classification is a powerful testament to the rigour of our Quality Systems and the discipline of our teams.”
He added that there had been “multiple products already filed from this facility, where we have recently added International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)-compliant stability storage capabilities”.
Founded in 1999 out of King’s College London, MedPharm is a contract service provider of topical and transepithelial drug products. It merged with Tergus Pharma in 2024 and currently has locations in both the US and UK. MedPharm delivers products for a wide variety of medical areas, including dermal/transdermal, lung and nasal, mucosal membrane and ophthalmic.
Investors in MedPharm include Ampersand Capital Partners and Bourne Partners Strategic Capital.
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