Overview

Our 110,000 sq. ft. facility in Durham, NC, is built to perform research, development and regulated GMP clinical and commercial manufacturing. Facility access is key card controlled, and areas which require additional restricted access are also key card controlled.

• GMP Warehouse
• Manufacturing and Packaging
• Unfinished future space for build out
• Laboratories
• ICH Stability Chambers

Capabilities include:

• Analytical Testing
• Manufacturing & Packaging of Toxicology
• GMP Clinical (Phase I, II, III)
• Commercial Drug Product batches

Stirrup Creek contains the following lab areas:

• QC Analytical Lab
• Characterization Lab
• R&D Analytical Lab
• Formulation Development Lab

Building and Facilities

• USP Purified Water System
• Nitrogen Tank
• Compressed Air
• Backup Generator
• All compounding and filling areas meet ISO 8 requirements
• Dedicated High Potency Suite serviced by a dedicated HVAC unit

ICH Stability Chambers

ICH stability chambers are now in operation at MedPharm’s Stirrup Creek manufacturing facility and enable the company to support ICH-compliant stability storage across a wide range of development programs. The chambers are fully qualified and ready to support programs? requiring controlled environmental conditions.

Strategic Advantages of In-House ICH Stability Chambers

• Regulatory Readiness: Enables full compliance with global regulatory expectations (ICH Q1A), supporting INDs, NDAs, ANDAs, and international filings.
• Operational Efficiency: Reduces dependency on external vendors, streamlining timelines and improving control over study execution.
• Cost Optimization: Minimizes outsourcing costs and accelerates decision-making for formulation and shelf-life assessments.
• Enhanced Client Offering: Strengthens our technical capabilities and expands our service portfolio for partners seeking end-to-end development support.
• Data Integrity & Security: Ensures secure, traceable, and audit-ready data generation within our own controlled environment.