Polpharma API Business Unit takes advantage of entering into a new, highly specialized area of highly potent API development and manufacturing as an essential milestone in our growth strategy.
A new greenfield R&D and production facility dedicated to HP API products with OEL down to 10ng/m3 3(OEB 6) will be launched in Q3 of 2024.
The plant capabilities shall provide GMP and FDA-approved kilo-scale production of batch sizes up to 1,5 kg together with separate analytical (ADL) and process development laboratories (PDL).
The plant's design assumes best-in-class isolator technology for personnel and product safety and all industry-standard secondary containment solutions built into the planning infrastructure.
Further future expansion is foreseen and secured by internal and external expansion capabilities, aiming to double the necessary production capacity, allowing us to grow both internally and with our CDMO business partners.