If you find a non GMP product in our offering and you are interested in using this in a pharmaceutical application, we would like to discuss this with you. We have a large interest in expanding our GMP-product offering. Our warehouse and processing qualifications allow us to store, package, and ship the APIs that we manufacture.

Histamine Dihydrochloride

We produce Histamine as an API. It is used, for example, as an allergy test standard after it was unexpectedly declared to be an API by a regulator. We have developed Histamine, GMP with a large industrial partner and are currently capable of delivering kilogram quantities.

5-Aminolevulinic Acid Hydrochloride

We own the DMF for this product for applications such as photodynamic therapy. We have no binding affiliation to a pharmaceutical manufacturer and are free to distribute. Our product is already used in a number of commercial formulations and is approved by the European Medicines Agency (EMA). We can also make this material in bulk quantities.

Orphan Drugs

Non-GMP manufactured chemicals may be used as APIs for the treatment of rare diseases. Under certain circumstances, if no GMP-quality material is commercially available, it is possible to use non-GMP quality instead. Partner with us to take your non-GMP ingredient and make it into a proper API.

Controlled Substances

Our Swiss facility is highly secured and equipped with biometric access control. In this facility we are qualified to manufacture, store, and sell controlled substances – if you need to handle, ship or package controlled substances (or APIs), we are your ideal partner.

Related Documents

Biosynth's ISO and GMP Certificates and the PMDA Compliance Inspection Result Notification are available here:


Related Service

R&D project

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Related Products

Histamine x 2HCl, GMP


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5-Aminolevulinic acid hydrochloride, GMP


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