• Home
  • Applications
  • Pharma
  • Active Pharmaceutical Ingredients (API)

    • 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 from Dr. Paul Lohmann
    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. 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.

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

    Information regarding our obligations to provide notice regarding the processing of personal data in accordance with Articles 13 and 14 of the GDPR can be found in our privacy policy.

    German Manufactor German Manufactor Cart

    Sample Request

    Layers

    Product Finder

    Chat

    Contact