Manufacturing solutions for the health care industry
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In 2015 Esteve Química decided to increase its current manufacturing capabilities with potent compounds. To this end, the decision was made to install the following units —to be ready by late 2016:
A laboratory for high-potency APIs located at our R&D center in Barcelona. This laboratory will be equipped to work with OEL above 0,1 μg/m³ and will perform process development (under cGMPs if needed) with the possibility of manufacturing under future cGMPs very low commercial HPAPIs (annual quantities below 500g).
A manufacturing unit allowing HPAPIs to be manufactured under cGMPs with OEL above 1 μg/m³. The batch size for this unit will be between 3-15kg. Filtration and drying will be performed in a Hastelloy filter dryer.
Esteve Química has 50 years of experience developing, manufacturing and marketing oral and injectable-non-sterile APIs (NCEs and generics) for regulated markets. In addition to our generics business, we currently offer a complete range of services —from API manufacturing to finished product formulation— by establishing alliances with strategic pharmaceutical manufacturers and partners.