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Competencies & Services
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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.

Polpharma’s strategic investment in HPAPI facility
We have launched an investment in a specialized facility
for the R&D and Production of highly active substances
with an OEL value of 10 ng/m3 (OEB 6).

The HP API investment includes separate process
laboratories (PDL), analytical laboratories (ADL)
with the possibility of performing Quality Control
analyses, and a GMP kilo-lab production line with
volume up to 1.5 kg with potential volume increase.

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