Wide portfolio of GMP-compliant Generic APIs

Cityscape of Milan with the illuminated Galleria Vittorio Emanuele II arch on the left and the Milan Cathedral on the right at dusk, with text promoting CPHI event in Milan from October 6-8, 2026, and a green button labeled '# 7A50'.

Core competencies

Our DMF documentation for all products is meticulously prepared to comply with the latest standards set by EDQM (CEP), ICH (ASMF in eCTD format), and FDA (US DMF). We conduct material and product testing in accordance with the European and United States Pharmacopeias, ensuring the highest quality and regulatory compliance.

USFDA

EDQM/EMA

Polish MOH

SKFDA

ANVISA

PMDA

Quality harmonization

A man working on a API R&D laboratory equipment

We adhere to the highest quality standards that meet global requirements. Our robust and validated quality system enables you to significantly reduce your QC testing efforts while ensuring reliability and compliance.

Our core competencies form a strong foundation for ensuring customer satisfaction through the highest quality products delivered via environmentally friendly processes. At our FDA-approved facility in Central Europe, we offer comprehensive end-to-end solutions that encompass API development to scale-up. This allows for seamless process transfer to commercial-scale manufacturing, supported by world-class regulatory expertise.

Our highly qualified experts guarantees that the quality of our products is upheld at every stage of the production process. We strictly adhere to cGMP procedures and maintain comprehensive documentation through well-defined SOPs. Additionally, our state-of-the-art quality control laboratory ensures that the APIs produced by Polpharma consistently meet the highest quality standards.

QC testing according to both Ph. Eur. and USP monographs

We provide you with one batch which has been certified in accordance with the US and the Ph. Eur. Pharmacopeias based on your request. This will allow you to use this batch for whichever market, according to your needs.

Laboratory equipment on the API manufacturing site

Live Digital Tour at our API Plant

Visit us from anywhere!

‍We provide remote solutions for visits, audits, and ongoing project follow-ups, utilizing cutting-edge virtual conference technologies. Experience a customized live tour of our main API facility located in Starogard Gdański, Poland, tailored to your specific needs.