High Potency APIs

High Potency APIs (HPAPIs)

Ash Stevens is a leader in the development and cGMP manufacture of high potency active pharmaceutical ingredients (HPAPIs).

As a longstanding provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI), Ash Stevens has extensive experience and an impeccable safety record working with high potency anti-cancer agents and other highly potent therapeutics. Our state-of-the-art manufacturing facility in Michigan features all necessary engineering and containment controls for the safe handling and cGMP manufacture of small and large-scale HPAPIs – with OELs ≥ 1.0 µg/m3. Potent molecule manufacturing is a complex process, and long-term experience, state-of-the-art facilities and robust operational and safety systems make Ash Stevens an ideal manufacturer for HPAPI projects.

API Manufacturing

Ash Stevens has a longstanding track record and reputation as a preferred supplier of innovator APIs.

Analytical Support

Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.