We import active pharmaceutical ingredients (API) and excipient substances from selected sources having documentation required for EU and non-EU markets. Our offer includes API from all therapeutic groups.

We provide our customers with complete API documentation required for preparing registration dossier and MA applications. We are actively involved in arrangement of laboratory samples, working standards of API and/or impurities. We provide permanent assistance in obtaining all API documentation necessary for requalification of API sources and in updating of Marketing Authorizations by our customers. We also provide help in organizing quality audits at API manufacturing sites. The technical support during the entire process of API approval and requalification procedures is of our utmost attention.

Our import services are highly appreciated by the customers. We have a status of the qualified supplier based on our clients audits and we are reaching the highest scores in periodic cooperation evaluations. Most of our API supplies go directly to the enduser’s warehouse but we also distribute a range of substances form our API warehouse in Ciechanow. We have a quality system being in line with the guidelines and regulations of EU authorities.

Acting as per the guidelines of Directive 2011/62/EU we have duly submitted in March 2013 our application for including POLFA S.A. in the national register of API IMPORTERS AND DISTRIBUTORS.

Export

As exporters, we operate mainly (but not exclusively) on Asian (Vietnam, Kazakhstan) and both Central and Eastern European (Poland, Hungary, Ukraine, the Czech Republic, Belarus, Bulgaria and many other) markets. We provide comprehensive support for foreign transactions, as well as a reliable and stable level of sales..