The company was originally founded at this site in 1935 as the Polish Chemical and Pharmaceutical Factory, “Polpharma”, after which the plant was significantly damaged during World War II.
In the years 1945–1949, factories were nationalised and rebuilt. In 1951, the enterprise changed to Starogardzkie Zakłady Farmaceutyczne. The company was restored to its former name “Polpharma” on 1 December, 1995, and was privatised on 20 July, 2000, with the participation of Polish capital.
Drug Production Plant
There are 575 specialists employed in the Drug Production Plant and 1500 products are manufactured here. The plant is constantly expanding, particularly in the areas of glass ampoules, polypropylene infusion fluids and dry mould production capacity.
Plant for the Production of Highly Potent Substances (HP API)
In 2024, we launched an innovative facility for the development and production of highly potent substances (High Potent API) worth over 100 million PLN, enabling the production of key substances used in the treatment of oncological diseases, multiple sclerosis, and spinal muscular atrophy (SMA). Thanks to advanced technologies and the highest safety standards, Polpharma is becoming a leader in HP API production worldwide.
Polpharma focuses on highly specialized substances requiring advanced competencies. Currently, on a commercial scale, we produce 41 active substances. Most of them are produced at the API plant in Starogard Gdański, with a few coming from the API plant in Warsaw. Our substances are available in 70 countries across 6 continents.
The new facility allows for the development and production of APIs with an Occupational Exposure Limit (OEL) of up to 10 ng/m³. The facility enables production in compliance with GMP and FDA guidelines.
We manufacture our products according to the highest standards set by our clients and health institutions. Our DMF documentation for all products is prepared in accordance with the latest regulations: EDQM (CEP), ICH (EU DMF, CTD), and FDA (US DMF). Additionally, all material and product tests are conducted in accordance with the European and United States Pharmacopeia, ensuring the highest quality.
We have suppliers in various parts of the world and audit them at their production sites. Polpharma’s API production areas are subject to rigorous inspections by the U.S. Food and Drug Administration (FDA). We have undergone FDA inspections in 2004, 2009, 2012, 2015, and 2018, all of which were successful, confirming our reliability and credibility among business partners worldwide.
Our flexible collaboration models allow us to meet the needs of our partners. By working closely with other entities in the pharmaceutical sector, we achieve shared successes and deliver innovative, effective therapies for patients. Together, we strive for progress in healthcare.
For more information, please visit: www.api.polpharma.com