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 nine certified APIs for market supplies exclusively for our customers on a regular basis.

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Synthesis development

We have more than 30 years of experience in the development of organic syntheses for drug substances (APIs).

On receipt of an order for synthesis development we first research the latest state-of-the-art and conduct a feasibility study if applicable. This includes the proposed synthetic route, a schedule and a cost estimate for the execution of the necessary development work. It may also include an estimate of the future manufacturing costs for the drug substance.

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Analytical development

In addition to synthesis and drug development, we offer a comprehensive range of analytical services (incl. stability testing). Our range includes both routine analysis according to pharmacopoeial methods as well as the development of new analytical methods for drug substances and drug products.

We have many years of experience in using gas chromatography (GC/MS, GC/FID) to determine residual solvents in pharmaceutical ingredients, drug substances (APIs) and drug products.

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