Competencies & Services
Competencies & Services
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, one of the top CDMO companies producing APIs in Europe,
engages with clients’ projects from early-stage clinical candidates to
commercial launch and across the whole product life cycle. We provide
our clients with a broad range of services across all the value chain thanks
to our state-of-the-art facilities (R&D, pilot, manufacturing, and QC)
and long experience in the development and manufacturing of highly
complex active pharmaceutical ingredients.
Among key technologies, expertise, and CDMO services that we
can provide to our partners there are:
R&D laboratories:
- Process chemistry, from full development to transfer to production
- Analytical methods transfer, development, validation
- Process development, process optimization
- Second generation process for cost control
FDA approved GMP facilities from pilot plant scale to
multi-ton manufacturing scale.
Security of supply assured by network of well-established partners
or back integration of intermediates and starting materials.
State of the art QC laboratories for product release.
Dedicated Project management to ensure the best possible
customer experience.
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.