News
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs), that is proceeding with a $45-million manufacturing expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from 2024 with full completion scheduled for Q3 2024.
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.
We manufacture our products by following our customers' and health authorities' most stringent requirements. DMF documentation for all our products is prepared in accordance with the latest requirements of EDQM (CEP), ICH (EuDMF, CTD), and FDA (US DMF). Material and product testing is performed in line with the European and United States Pharmacopeias.
We are a Poland-based CDMO and manufacturer of active pharmaceutical ingredients (APIs) that is proceeding with a $35-million facility expansion of its main API plant in Starogard Gdanski to include HPAPI and cryogenic technologies and investments in a pilot plant and R&D capabilities. We expect to extend our operations starting from Q1 2024, with full completion scheduled for Q3 2024.
First CADIFA certification from ANVISA for Etodolac
First CADIFA certification from ANVISA for Etodolac In the dynamic […]
KiloLab Laboratory:
strategic milestone
achieved!
Another Polpharma API strategic milestone achieved! KiloLab Laboratory – a […]
Ryvu Therapeutics and Polpharma sign two agreements in the area of RVU120 active substance (API) production for Phase II clinical trials
Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development […]
Cryogenic infrastructure at API facility
Polpharma is able to meet new challenges thanks to the […]
Liophilization: What does a strawberry
have in common with Polpharma API?
On November 2022, at Polpharma API Plant, we implemented freeze-drying […]
Polpharma’s strategic investment in HPAPI facility, the first of this kind in Poland
In 2022, we are opening a new chapter in the […]
Safe approach in delivering nitrosamine-free API products
N-nitrosamine impurities have been in the news for some years […]
Polpharma partners with Pikralida biopharmaceutical start-up
Polpharma has established cooperation with Pikralida, a biopharmaceutical start-up that […]
September 2019 was the date when the transformation process started in the API Business Unit of Polpharma.
This process targets clear information flow from an efficiency perspective based on KPIs, facilitating rapid…
Searching for new, better, and innovative solutions. Digital Transformation at Polpharma API.
People and their ability to change are the key drivers of each transformation.
Polpharma API Business Unit (API BU) completed step 1. Risk Evaluation according to EMA’s request concerning presence of nitrosamines in drug products.
As of September 26, 2019, EMA’s Human Medicines Committee (CHMP) requested as a matter of…
Why particles size is important in pharmaceutical industry? Is it really problematic?
In the pharmaceutical industry, particle size has become one of the key aspects in the…