Saturday, 27 November 2021 English Español Català COMPANY PRODUCT & SERVICES THE GROUP OUR QUALITY NEWS CONTACT Regulatory Affairs Home > Our quality > Regulatory Affairs Moehs Group produces and sells more than 200 products worldwide in more than 90 countries. Among other activities, the Regulatory department is in charge of the Technical Assistance to customers and it is responsible of the DMF registration of our different APIs in more than 30 countries (including USA, Europe, Russia, Canada, Brasil, China, Korea, Japan, Africa , Australia, New Zealand, and others). In fact, we are holders of more than 80 DMFs registered worldwide, 29 USDMFs filed at the FDA for the US market and 16 J-DMF filed in the PMDA for the Japanese market. The European Department for the Quality of Medicines of the European Council has granted Certificates of Suitability (CEP or CoS) for 31 of our products and there is 1 dossier which is currently under assessment. Moehs regularly collaborates with the European Pharmacopoeia and USP for the elaboration of new and revised monographs for several products Additionally, Moehs periodically supplies to the EDQM and USP with reference standards of impurities and drug substances (CRS) 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 Home Privacy and Legal Advice Contact Work with us

Saturday, 27 November 2021 English Español Català COMPANY PRODUCT & SERVICES THE GROUP OUR QUALITY NEWS CONTACT The Group Home > The Group Moehs Ibérica Headquarters 08191 Rubí (Spain) T.+34 93 586 05 20 More information Moehs Group Research Center 08191 Rubí (Spain) T +34 93 586 05 20 More information Moehs Catalana 08191 Rubí (Spain) T +34 93 586 05 20 More information Moehs Cantabra 39313 Polanco (Spain) T +34 942 131 045 More information Coprima 08213 Polinyà (Spain) T +34 937 131 956 More information Moehs BCN 08755 Castellbisbal (Spain) T +34 935 860 520 More information Norchim S.A.S 60340 Saint Leu D’Esserent (France) Tel: +33 (0) 3 44 56 09 20 More information Benechim S.p.r.l 08494 Rubí (Spain) T +32 68 33 49 13 More information Proteos Biotech, S.L. 02006 Albacete (Spain) T +34 915 417 000 More information Chemische Fabrik Berg GmbH 06749 Bitterfeld – Wolfen (Germany) T: +49 34 935 166 180 More information ZETA Pharmaceuticals L.L.C. 2103B West Ferry Way SW. Huntsville, AL 35801. More information Moehs Ibérica Malta branch SOHO The Strand Fawwara Building Triq I-Imsida Gzira GZR 1401 Malta Moehs Ibérica Shanghai Office Atlas Workplace, Of.9FB08, Shanghai Sinar Mas Centre 501 Dongdaming Road, Hongkou District 上海市虹口区东大名路501号白玉兰广场9楼B08室 200080 Shanghai, China 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 Home Privacy and Legal Advice Contact Work with us