Security of supply
Security of supply
While working on your Drug Substance we will take care of entire supply
chain for all the materials required to secure on time production and delivery.
- Well established and controlled suppliers qualification process:
- Paper Audit
- Personal on site Audit (For Intermediates and selected Regulatory Starting Materials)
- Risk based approach.
- Managed by separate QA Team dedicated for Suppliers Qualification.
- Own Team of well-trained auditors. Auditors employed by Polpharma having seat in Asia.
- Periodic requalification (Every 3 years).
- Broad network of reliable European suppliers qualified for solvents and basic
chemicals that are in common use in API production. - Wide group of high quality, GMP compliant suppliers for Intermediates
and Starting Materials qualified by Polpharma ready to produce custom
intermediates on exclusive basis. - Multipurpose lines giving flexibility in planning and enable
to implement your process in different lines as a contingency plan. - Experienced Regulatory affairs group supporting clients
in CMC package preparation for filing
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from mid-2023 with full completion scheduled for Q1 2024.
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.
Our products are manufactured in accordance with the most stringent requirements of our customers and health authorities. 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. Our products can be additionally tested in compliance with the customer’s specifications.
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from mid-2023 with full completion scheduled for Q1 2024.