Simple. Fast. Approved.

The approval of pharmaceutical ingredients and drugs is subject to extensive legal regulations. Not least, it calls for a great deal of data to be ascertained and processed so as to complete the necessary approval documents. We can provide our customers with optimum support – also thanks to our intensive collaboration with national and international supervisory authorities and approval bodies or pharmacopoeia committees.

BASF has extensive experience as well as detailed knowledge of the approval procedures and requirements in a wide variety of countries. We compile the so-called Drug Master Files (DMF) or comparable approval dossiers for all our active ingredients, excipients and exclusive ingredients. These documents contain data on the production process, materials used in production, physical and chemical properties as well as the quality control and stability of the product. They are filed at the relevant supervisory authorities, such as the American FDA or the European Health Authorities. Customers of BASF can refer to the corresponding Drug Master File in their registration procedure. We respond immediately to new or modified requirements of the authorization bodies. The Drug Master Files are checked annually and, if need be, updated.

Substances covered by a monograph in the European Pharmacopoeia are certified by BASF at the relevant supervisory authority, the European Directorate for the Quality of Medicines (EDQM). As a result, the approval is considerably simplified for our customers on the basis of the so-called Certificate of Suitability.