Global Active Pharmaceutical Ingredients (API) manufacturer Medichem opens today a brand new High Potency API unit (HPAI) in its Maltese plant, located in Hal Far (Malta).

With this new offering, Medichem wants to consolidate its presence in the generic pharmaceutical industry. “Our expansion to HPAI field will allow Medichem to offer a broader product portfolio to our customers. Today, 25% of new drugs in development are highly potent, and we expect this tendency to keep growing”, explains Ervin Veszprémi, CEO of Medichem.

The HPAI modular laboratory is a multipurpose facility that is fully equipped for the synthesis of HPAIs from the very early R&D phases, through process development and to manufacturing allowing Medichem to produce Class 4 HPAIs with OEL down to 40 ng/m3. It is composed of different areas dedicated to R&D and Kilo-lab activities. The Kilo-lab unit is equipped with 10L, 20L reactors, filtering, drying, milling and micronizing equipment. R&D work and production are expected to begin in the second half of 2014.

The global demand for HPAIs is growing due to the ability of this class of molecules to target diseases while being more effective at very low doses. They are usually used in therapies such as oncology and musculoskeletal treatments among others. Typical highly potent compounds are hormones, narcotics and retinoids. Many generic companies are looking for partners who can provide a high quality and reliable supply of highly potent products within current Good Manufacturing Practices (cGMP) and FDA inspected environments and Medichem is able to fulfill these requirements. Moreover, the unique patent situation of Malta allows Medichem to develop and produce HPAI in advance of patent expiry. This legal /IP framework allows Medichem to offer first-to-market opportunities to its customers worldwide.