cGMP Contract Manufacturing for Clinical Supplies and Commercial Drug Products

For more than 50 years, UI Pharmaceuticals has supported pharmaceutical and biotechnology sponsors at every stage of the product lifecycle — from early-phase clinical supplies to fully commercialized drug products. As an FDA-registered drug product manufacturer, we bring the rigor of a fully audited cGMP facility with the flexibility of a university-based CDMO.

Our Clinical and Commercial Manufacturing Capabilities

UI Pharmaceuticals manufactures both sterile and non-sterile drug products for clinical trials and commercial sale in the US and international markets. Our manufacturing capabilities include:

Sterile Products

• Sterile fill/finish for injectable products (vials, ampules)
• Lyophilization (freeze-drying) for stability-sensitive formulations
• Currently producing and distributing a commercially approved sterile solution in the US

Solid Oral Dosage Forms

• Tablet and capsule manufacturing and testing
• Small-scale production optimized for clinical supply needs

Semisolid and Non-Sterile Products

• Gel and cream formulations
• Currently manufacturing a non-sterile gel drug product distributed in the US, EU, Israel, and additional international markets

Controlled Substances and Potent Compound Handling

UI Pharmaceuticals is equipped to manufacture drug products across a broad range of compound classes, including:

• Controlled substances — Schedule I–V (DEA-licensed)
• Potent and cytotoxic compounds — with appropriate containment controls
• Large and small molecules — across multiple therapeutic categories

Quality-Driven Manufacturing Since 1974

Clinical and commercial supply manufacturing is a core part of what we do. Since 1974, every product manufactured at UI Pharmaceuticals has been produced and tested under:

• Strict batch records
• Documented standard operating procedures (SOPs)
• Full cGMP controls

All manufacturing operations undergo post-completion audit by our Quality Assurance Group, ensuring compliance at every step.

FDA-Registered Facility

UI Pharmaceuticals is registered with the FDA as a drug product manufacturer. We have a proven track record of producing and testing sterile and non-sterile products that have successfully reached commercial markets — and we are actively working with sponsors whose products are currently in the US registration process.