European CDMO Partner and API Manufacturer since 1951
FDA-APPROVED AND
cGMP-COMPLIANT PRODUCTION SITE
CDMO
Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.
Generics
We manufacture our products by following our customers’ and health authorities’ most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.
Technologies
Polpharma API CDMO (Contract Development and Manufacturing Organization) supports emerging and large pharmaceutical customers in the development and commercialization of their small-molecule APIs clinical candidates thanks to +70 years of experience in process development, scale-up, and cGMP manufacturing of small molecule APIs in volumes ranging from kilos to tens of tons.
Polpharma API
We are proud of our 70 years of experience in supporting patients’ health with high quality APIs and becoming a leading European CDMO partner.
Our core competencies are a solid foundation to assure customer satisfaction through the highest quality of products delivered with environment-friendly processes. At our FDA-approved plant located in Central Europe, we provide end-to-end solutions from API development to scale-up, allowing smooth process transfer for commercial-scale manufacturing capabilities with a world-class regulatory support.
API Manufacturing Sites
Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the natural environment.
We have the capabilities to provide customers with materials ranging from clinical quantities up to the in-market supply. We have full and vertical integration of processes from R&D, pilot plant, and scale-up to the manufacturing leverage of our competencies in place so that cost-effective and on-time solutions are delivered to our partners. API manufacturing is carried out in a cGMP-compliant and FDA-approved multipurpose plant.
Polpharma Group
For over 80 years, trusted by patients, healthcare professionals, and business partners alike. A leading regional (CEE and CIS) manufacturer of pharmaceuticals and a leader in the Polish & Kazakhstan pharmaceutical market. Actively operating in Central and Eastern Europe, the Caucasus, and Central Asia markets.
Polpharma is one of the frontrunners in transforming the healthcare industry in terms of advanced commercial models, use of AI in industrial and other areas to further improve both the closeness to the HCP professionals and patients and its effectiveness.