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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, South Korea, Japan, African countries, 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, many other MOEHS dossiers 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).

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  • Headquarters:
  • Pol. Ind. Cova Solera
  • c/Roma, 8-12 08191 Rubí.
  • Barcelona (Spain)
  • T +34 93 586 05 20
  • Fax +34 93 588 85 13
  • info@moehs.es

Partnering companies

The Board of Directors of the Center for Technological Development and Innovation, E.P.E (CDTI), in its meeting held on 02/23/2023, approved the participation of this center in the research and development project called SYNTHESIS OF A STIMULATOR ACTIVE PRINCIPLE OF SOLUBLE CYCLASE GUANYLATE by granting partially reimbursable aid.

The objective is focused on the development of a new method of chemical synthesis of an active ingredient that stimulates soluble guanylate cyclase.

The project will be carried out at the Rubí facilities. The project execution period is from 2022 to 2024 and they have a financeable budget of €1,862,213.00.
This project is co-financed by the European Union and CDTI.

The Board of Directors of the Center for Technological Development and Innovation, E.P.E (CDTI), in its meeting held on 02/23/2023, approved the participation of this center in the research and development project called SYNTHESIS OF AN ACTIVE INHIBITOR PRINCIPLE OF JANUS KINASE FOR THE TREATMENT OF ATOPIC DERMATITIS.”, by granting partially reimbursable aid.

The objective is focused on the development of a new method of chemical synthesis of a janus kinase inhibitor active ingredient for the treatment of atopic dermatitis.

The project will be carried out at the Rubí facilities. The project execution period is from 2022 to 2025 and they have a financeable budget of €1,940,409.
This project is co-financed by the European Union and CDTI.