{"id":27198,"date":"2022-04-28T14:12:49","date_gmt":"2022-04-28T12:12:49","guid":{"rendered":"https:\/\/endotherm-lsm.com\/auftragssynthesen\/arzneimittelzulassungen"},"modified":"2023-02-08T15:53:34","modified_gmt":"2023-02-08T14:53:34","slug":"arzneimittelzulassungen","status":"publish","type":"page","link":"https:\/\/endotherm-lsm.com\/en\/auftragssynthesen\/arzneimittelzulassungen","title":{"rendered":"Drug approvals"},"content":{"rendered":"\n
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Drug approvals<\/h1>\n<\/div><\/div>\n\n\n\n
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Production of API laboratory samples<\/h2>\n\n\n\n

For the approval of new drugs, you will receive laboratory samples of active pharmaceutical ingredients (API) in quantities of up to 1 kg.<\/p>\n\n\n\n

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 (1<\/sup>H\/13<\/sup>C-NMR, HPLC or LC\/MS), inorganic impurities, melting point, X-ray diffraction, and a corresponding certificate (CoA).<\/p>\n<\/div>\n\n\n\n

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In addition, we provide the desired active pharmaceutical ingredients for metabolic studies (labeled on demand) and prepare by-products and impurities for toxicity testing.<\/p>\n\n\n\n

The Endotherm Life Science Molecules team specializes in synthetic chemistry for API production and has extensive knowledge of regulatory requirements for drug approval:<\/p>\n\n\n\n