We support patients’ health and the sustainable development of the Polpharma Group by being a reliable and responsible manufacturer of high-quality APIs
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.
Why to choose Polpharma API?
API/CDMO competencies
From process development to
large-scale production
Highest quality of
product sand cost-
competitive processes
Cost competitive vs. Western EU, US, JP
European location of manufacturing
plants
Fast decision making
and execution
Fully integrated Business Unit,
a lean organization
Key Numbers
35
mln Euro
new Highly potent
API manufacturing
site investment
70
Countries
Europe, USA, Japan, Canada,
China, Brazil, Korea and
many others
70
API Products
in portfolio from
different therapeutic
groups
450
Employees
in Polpharma API
Business Unit
65
Patents
72
mln $
turnover by sales
+70
Years
of worldwide experience
in API production
2
API Manufacturing Sites
located in Europe
Regulatory Fillings
DMF documentation for all our products is prepared in
accordance with the latest requirements.
CANADIAN DMF
14
US DMF
37
BRAZILIAN
CADIFA 2
pending 10
EU DMF
53
CEP
24
Chinese DMF
11
Japanese DMF
14
Korean DMF
20
Our team of highly educated experts ensures that our products’ quality is maintained at all stages of the production process. Strict compliance with cGMP procedures, well-documented SOPs, and a modern quality control laboratory ensure that APIs produced by POLPHARMA are of the highest quality.