MedPharm’s topical drug product manufacturing facility in Durham has successfully completed a U.S. Food and Drug Administration (FDA) inspection for commercial manufacture of drug products.

“I am pleased to mark this significant milestone, which reflects our organization’s unwavering commitment to quality and our continued focus on operational excellence,” said Bill Humphries, CEO of MedPharm. “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.”

Humphries added, “Receiving an FDA inspection outcome with no Form 483 issued and NAI classification is a powerful testament to the rigor of our Quality Systems and the discipline of our teams. With multiple products already filed from this facility, where we have recently added ICH compliant stability storage capabilities, we look forward to additional approvals as we continue expanding our manufacturing footprint and delivering exceptional value to our partners and the patients they serve.”

MedPharm’s purpose-built 110,000-square-foot facility in Durham accommodates research, development, analytical laboratories and robust quality assurance systems that complement the site’s CGMP clinical and commercial manufacturing capabilities for semi-solid dosage forms.