We are an established order and contract manufacturer of active pharmaceutical ingredients (drug substances) and selected intermediates ranging from milligrams to kilograms.
Our production follows cGMP and is in accordance with the EU-GMP-Guideline Part II (ICH Q7). We are regularly inspected by the responsible local authority which issues us with drug substance-specific GMP certificates. We are currently manufacturing seven certified APIs for market supplies exclusively for our customers on a regular basis. Our range of substances does not include any hormones/steroids, cephalosporins/penicillins or cytostatics.
If it becomes necessary to manufacture larger quantities of drug substances we work with selected partners to realize batch sizes of up to 1,000 kg.
Our manufacturing services in detail
- Manufacture of active pharmaceutical ingredients (APIs)
- Manufacture of drug substances for toxicological and clinical trials
- Manufacture and certification of reference substances
- Manufacture of by-products and degradation products as well as metabolites
- Validation of manufacturing and purification procedures
- Complete GMP documentation (Master Production Instructions, Batch Production and Control Records)
- Consulting on all matters relating to the production of APIs (incl. identification of contract manufacturers)
|Substance name||CAS no.||Molecular formula||Quality|
|Anagrelide hydrochloride monohydrate||823178-43-4||C10H10Cl3N3O2||USP|
|Atipamezole hydrochloride||104075-48-1||C14H17ClN2||Purity HPLC: ≥ 99.8 area percent|
|Clenbuterol hydrochloride||21898-19-1||C12H19Cl3N2O||Ph. Eur.|
|Detomidine hydrochloride||90038-01-0||C12H15ClN2||Ph. Eur.|
|Medetomidine hydrochloride||86347-15-1||C13H17ClN2||Purity HPLC: ≥ 99.8 area percent|
|Nabilone||51022-71-0||C24H36O3||Purity HPLC: ≥ 99.0 area percent|
|Phenoxybenzamine hydrochloride||63-92-3||C18H23Cl2NO||Purity HPLC: ≥ 99 area percent|
|*Certain restrictions may apply in some regions.|