Production of API laboratory samples
For the approval of new drugs, you will receive laboratory samples of active pharmaceutical ingredients (API) in quantities of up to 1 kg.
In accordance with DIN EN ISO 9001:2015-certified internal processes and documents and depending on the project, you will receive GLP-ready substances with a detailed manufacturing process developed experimentally by us. You will receive comprehensive analytical data (1H/13C-NMR, HPLC or LC/MS), inorganic impurities, melting point, X-ray diffraction, and a corresponding certificate (CoA).
In addition, we provide the desired active pharmaceutical ingredients for metabolic studies (labeled on demand) and prepare by-products and impurities for toxicity testing.
The Endotherm Life Science Molecules team specializes in synthetic chemistry for API production and has extensive knowledge of regulatory requirements for drug approval:
- Efficient synthesis routes for the production of innovative active ingredients (e.g., stereoselective 20-step process for the synthesis of 50 g Alvimopan, patent application for a new process for the production of 500 g Bempedoic acid)
- Production of active pharmaceutical ingredients of the highest purity (>99%)
- Cost-efficient development of synthesis processes