CPL Sachse Wirkstoffproduktion

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.

CPL Sachse Wirkstoffproduktion

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.

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 Salary standards of the highest quality.

Available reference substances