About Us

European CDMO and Gx manufacturer
with 70 years of experience in supporting patients’ health ​with high quality APIs

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Polpharma API
API Manufacturing Sites

Polpharma API

API R&D laboratory team working together

Our flexible cooperation models enable us to meet the specific needs of our partners. By collaborating closely with others in the pharmaceutical sector, we achieve shared successes and provide innovative, effective therapies for patients. Together, we are dedicated to advancing healthcare through strong partnerships.

We are open to various models of cooperation:
  • Contract Development and Manufacturing (CDMO): We work with partners throughout development and manufacturing, participating in the full product lifecycle, from idea to launch.
  • Supplies of APIs from our own development: We supply substances that we have developed ourselves, in accordance with our quality standards. 
  • Co-development: We are happy to engage in the joint development of new substances, which allows for the sharing of knowledge and experience, as well as for faster introduction of innovations to the market.
  • Contract Manufacturing (CMO): We offer manufacturing services to other companies, which can be beneficial if they need manufacturing support but still want to focus on other aspects of their business.

Why partnerig with Polpharma API?

High Potent API manufacturing facility instrument

Capabilities

Broad type of technologies with end-to-end solutions from process development to
large-scale production

Global reach

FDA-approved plant located in Central Europe with presence on +70 markets around the world

Fast execution

Fully integrated Business Unit,
from R&D, IO, Supply Chain to Commercial with fast-decision making

Key numbers

+70
years of experience
2
European manufacturing sites
70
markets
65
patents
450
employees
+70
products
6
continents
35
audits per year

Regulatory Filings

We manufacture our products in strict accordance with the highest standards
set by our customers and health authorities. Our DMF documentation for all products is prepared to comply with the latest regulations: EDQM (CEP), ICH (EU DMF, CTD), and FDA (US DMF). Furthermore, all material and product testing is conducted in alignment with the European and United States Pharmacopeias,
ensuring the utmost quality and compliance.

World map with API certification authorities.
API Manufacturing
Starogard Site View
Warsaw Site View

API Manufacturing Sites

Polpharma API building

We are the largest Polish manufacturer of active pharmaceutical ingredients. Our substances are available in over 60 countries on six continents. We employ the latest technologies to ensure the safety of our products, protect our employees, and safeguard the natural environment.

We supply quantities ranging from clinical trials to full market supply. Our fully integrated vertical processes ensure that we deliver cost-effective and timely solutions to our partners. API manufacturing takes place in a multipurpose facility that complies with cGMP standards and is FDA-approved, guaranteeing the highest quality and reliability.

Starogard Gdanski Site

33,1
ha
Manufacturing Site
6,2
ha
Area dedicated to API production
4,1
ha
Wastewater treatment plant
3
ha
Warehousing
(tank farm and solid raw materials)
123.k
m2
Total building surface
19.2k
m2
API production
10.7k
m2
Warehousing
7
buildings
Multipurpose buildings, 
Pilot Plant,
R&D
Laboratories
Starogard API manufacturing site map

Polpharma FDF

  1. Administration
  2. Adm. & Training Center
  3. R&D and QC Laboratory (Pharma & API)
  4. Finish Dosage Form Plant
  5. High Bay Warehouse
  6. Glass Production Site
  7. Polyethylene Production Site

API BU

  1. PS1-Hall 10/11
  2. PS2-Hall 26
  3. PS3-Hall 27
  4. PS4-Hall 17
  5. PS4-Hall 22
  6. PS5-Hall 28
  7. PP-Pilot Plant
  8. SRM-Solid Raw Materials Warehouse
  9. TF-Tank Farm
  10. QC1-”Wet Lab”
  11. QC2-Instrumental Lab
  12. UR-Workshop
  13. HP API Facility
  14. Photovoltaic Farm

Manufacturing plant

Polpharma utilizes up-to-date technologies, which ensure the safety of products, employees, and the natural environment.
‍
With reactor volume from 150 L to 6 000 L in 6 interconnected buildings, operating from -50°C to +200°C pressure up to 10 bar, and highly automated units for reaction parameters monitoring and control, we are being positioned among top European API CDMOs. We can accommodate a broad range of chemical processes to support customers in contract development and contract manufacturing projects.
‍
Segregated clean areas with a different types of equipment for isolation (nutch filters, centrifuges) and drying (filter driers, tray driers, vacuum driers). Milling and micronization to adapt particle size distribution to required customer needs.
Two employees working on a API manufacturing plant

Warsaw Site

1
Manufacturing Site
1
ha
Area dedicated to Polpharma API production
11
API Products
6
Intermediates
Warsaw API manufacturing plant map
Have a question?
Our specialists will be happy to guide you through our cooperation process.
Contact us