Perfection in every scale
API production
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 penicillins or cephalosporins as well as steroids or cytotoxic anti-cancer agents.
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)
Available APIs*
| 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. (CEP available) |
| Detomidine hydrochloride | 90038-01-0 | C12H15ClN2 | Ph. Eur. (CEP available) |
| Medetomidine hydrochloride | 86347-15-1 | C13H17ClN2 | Purity HPLC: ≥ 99.8 area percent |
| Methacetine (13C) | 72156-70-8 | C9H11NO2 | Purity HPLC: ≥ 99.0 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. | |||
Available reference substances
In addition to the production of active ingredients, we offer certified reference substances
of the active ingredients, by-products and degradation products as well as metabolites as identity or
assay standards of the highest quality.
Complete list of available reference substances (PDF)
