Contract Development
and manufacturing
Competences & Services
Competences & Services
Polpharma API CDMO (a contract development and manufacturing organization) supports emerging and large pharmaceutical customers in 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 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 development and manufacturing 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