Regulatory Issues

We produce and sell more than 200 products
to 90 countries

The Moehs group produces and sells more than 200 products worldwide in more than 90 countries. Among other activities, the Regulatory Department deals with Technical Assistance to customers and is responsible for the DMF registration of our different APIs in more than 30 countries (in the US, Europe, Russia, Canada, Brazil, China, Korea , Japan, Africa, Australia, New Zealand, among others).

In fact, we are holders of more than 80 registered DMFs worldwide, 29 registered USDMFs
in the FDA for the US market and 16 J-DMFs registered with the PMDA for the Japanese market.

The European Department for the Quality of Medicines of the European Council has awarded
the Certificate of Suitability (CEP or CoS) for 31 of our products and currently, and many other dossier are under evaluation.

Moehs regularly collaborates with the European Pharmacopoeia and the USP for the development of new monographs of various products, as well as their possible revisions.

In addition, Moehs periodically supplies EDQM and USP with reference standards for impurities and pharmaceutical substances (CRS).