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  • Active Pharmaceutical Ingredients (API)

    A wide range of more than 100 APIs is manufactured at our GMP-certified production sites in Emmerthal and Lueneburg.

    These APIs are used in drugs for the following therapeutic areas, among others:

    • Orthopedics
    • Hematology
    • Cardiology
    • Gastroenterology
    • Immunology
    • Nephrology
    • Neurology
    Mineral Salts as active pharmaceutical ingredients in tablets from Dr. Paul Lohmann®

    Regulatory Affairs

    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.

    Our CEPs

    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.


    CEP no.

    Calcium Acetate CEP 2011-033
    Ferrous Fumarate CEP 2004-232
    Ferrous Gluconate Hydrate CEP 2001-444
    Ferrous Sulfate, dried CEP 2007-368
    Ferrous Sulfate Heptahydrate CEP 2007-369
    Magnesium Aspartate Dihydrate CEP 2013-042


    CEP no.

    Magnesium Carbonate, heavy CEP 2008-071
    Magnesium Carbonate, light CEP 2010-062
    Magnesium Citrate CEP 2009-017
    Magnesium Citrate Nonahydrate CEP 2011-036
    Magnesium Hydroxide CEP 2013-020
    Sodium Dihydrogen Phosphate Dihydrate CEP 2019-228

    Your contact for pharma and biopharma

    Liesa Dißmeier


    Get in touch

    We recommend the following Minerals for use as active pharmaceutical ingredient (API):
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