MedPharm Strengthens Manufacturing Capabilities with Successful FDA Inspection
The CDMO’s North Carolina facility has successfully completed an FDA inspection thereby validating its quality systems and commercial readiness to reinforce its position as a leader in complex topical and transdermal drug manufacturing.
Topical, transdermal, and mucosal drug development CDMO, MedPharm, has completed an FDA inspection of its topical drug product manufacturing facility in Durham, North Carolina, with no Form 483 observations and a No Action Indicated (NAI) classification (1).The inspection outcome determined that the Durham facility’s quality systems, documentation, and manufacturing practices met FDA expectations and reinforced the site’s readiness for commercial manufacture of topical drug products.
For existing and prospective clients, the NAI classification at a commercial CGMP site reduces regulatory uncertainty around product approvals, shortens time-to-market, and provides confidence that scale-up and tech transfer can proceed from a robust, compliant operational base. Additionally, such a classification offers strong reassurance for sponsors looking to de-risk late-stage development and commercial supply in complex topical formulations.
“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,” said Bill Humphries, Chief Executive Officer of MedPharm, in a company press release (1). “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.”
Operating as a specialist CDMO, Medpharm offers integrated services from early formulation and in vitrotesting through to clinical and commercial manufacturing. From its facilities in Durham, North Carolina, and Guildford, UK, the company supports clients with research and analytical laboratories, CGMP semi-solid and liquid manufacturing, compounding, filling, packaging, and stability services, with a track record of successful FDA and MHRA inspections underpinning long-term strategic partnerships with pharma and biotech sponsors.
MedPharm’s recent FDA inspection outcome underscores its strong positioning within a CDMO market set for sustained growth. Demand for outsourced development and manufacturing continues to rise as pharmaceutical companies seek cost efficiencies, supply chain resilience, and solutions for increasingly complex drug products (2). Industry forecasts predict the global CDMO sector will expand from USD 168.75 billion in 2025 to USD 347.8 billion by 2035 (3), driven by greater pipeline diversity, the growing need for specialized dosage forms such as complex topicals and a continued shift toward partnership‑based models that emphasize quality, speed, and regulatory reliability — capabilities that MedPharm’s recent performance demonstrates it is well equipped to deliver.
References
MedPharm. MedPharm Announces Successful U.S. FDA Inspection of its CGMP Commercial Manufacturing Facility In Durham, North Carolina. Press Release, Jan. 7, 2026.
Future Market Insights. CMO/CDMO Market Size and Share Forecast Outlook 2025 to 2035. Market Research Report, Aug. 4, 2025.
Novo One Advisor. Pharmaceutical CDMO Market Size and Growth 2026 to 2035. Market Research Report, December 2025.