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API Synthesis

This division is engaged in the development and production of active pharmaceutical ingredients ranging from establishing laboratory processes through up-scaling to industrial-scale production. For this purpose, we have a modern in-house development and release testing department as well as appropriate regulatory support for the preparation of registration documentation such as DMFs and CEPs. Every development and manufacturing process is accompanied by extensive quality control and assurance measures in accordance with mandatory requirements.

  

  • Our expertise in the area of API synthesis dates back to the synthesis of galantamine in 1996. The technically complex and high-yield process for synthesising this substance culminated in the awarding of a global industrial synthesis patent valid until 2014 and enabled SANOCHEMIA to conclude an exclusive supply contract with Janssen-Cilag, a subsidiary of Johnson & Johnson with worldwide operations.

  

  • This knowledge base and the manufacturing processes it is based on give SANOCHEMIA a clear competitive edge when it comes to the stereo-selective synthesis of naturally occurring substances. Combined with outstanding levels of technical equipment, SANOCHEMIA is able to offer other players in the industry a comprehensive range of services associated with the development of complex APIs.
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