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. 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.

Substance	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

Substance	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