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These APIs are used in drugs for the following therapeutic areas, among others:
For pharmaceutical manufacturers, comprehensive documentation and regulatory support are essential to demonstrate the quality, safety and compliance of active pharmaceutical ingredients (APIs) and excipients.
At Dr. Paul Lohmann®, we combine decades of expertise in high-quality mineral salts with dedicated Regulatory Affairs competence to support our customers throughout the pharmaceutical development and registration process.
Our experienced Regulatory Affairs team manages the documentation of our broad portfolio of GMP-approved mineral salts and supports customers with the preparation of the required regulatory documents for international submissions.
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 | 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 |
Calcium
Iron
Magnesium
Potassium
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