These APIs are used in drugs for the following therapeutic areas, among others:
In the pharmaceutical industry, documentation is as important as the product (API) itself. We have established a Regulatory Affairs department that manages API documents such as CEPs (Certificate of Suitability to the Monographs of the European Pharmacopoeia), ASMFs (Active Substance Master File), DMFs (Drug Master File) and ASEAN-CTDs (Common Technical Document). Our regulatory affairs staff corresponds directly with the global health authorities after the MAH (Marketing Authorization Holder) submits the dossier. An APIMF (API Master File) for Zinc Sulfate 1-hydrate is available for WHO applications. Upon customer request, we are happy to develop new dossiers for compounds, including non-monographed substances or specific customer requirements.
For more information on certifications and documentation of our Mineral Salts please visit regulatory affairs.
A CEP allows the customer to register a drug in multiple countries in a cost-saving and simplified way. We have 12 CEPs listed with EDQM (European Directorate for the Quality of Medicines & HealthCare) and are working to extend this list, underlining the strategic direction of the company. The CEPs are recognized by all signatory countries of the European Pharmacopeia and the European Union. Canada, Australia, New Zealand, Tunisia and Morocco have also chosen to recognize them.