HPAPI – Highly Potent API

Our service for HPAPIs ranges from Drug Substance to Particle Engineering.

HPAPI – Highly Potent API

Many of NCE are considered potent compounds, meaning occupational exposure limits (OEL) <10 µg/m3, which requires special handling conditions. Hovione has invested in its facilities in Loures and New Jersey to provide the necessary containment, defined individual protection equipment and also developed working practices to safely handle these compounds.  

Our service for HPAPIs ranges from Drug Substance to Particle Engineering also for this for compounds with an OEL down to 1 µg/m3.  In the case of spray drying services Hovione can handle compounds with an OEL down to 0.03  µg/m3. Our multipurpose facilities that support Drug Substance services for HAPIs can go up to 2500L in volume.

This combination is unique in the industry and offers our customers the ability synthesize an HPAPI and then convert seamlessly to a spray dried dispersion all on the same site.

Also in Drug Substance Capabilities

Chromatography

Hovione has expanded its purification technologies to include chromatography to support development from lab to commercial scale.

Corticosteroids

Corticosteroids are produced in two dedicated buildings on the Loures site, which are equipped with vessels ranging from 50L up to 4000L.

Fluorinations

Hovione has a long history of carrying out reactions using hydrofluoric acid (HF) at commercial scale under a GMP environment.