ChemCon – Partner of Choice for your chemical and pharmaceutical R&D and small scale manufacturing needs

ChemCon commits itself to serve its customers with expert skills and high quality to assure fast success of projects. We are FDA inspected and specialized in contract research and custom synthesis. Our focus is the development of synthetic routes and small scale manufacturing (mg-to-kg) of Specialty Chemicals and Active Pharmaceutical Ingredients (APIs). We developed the process and are the manufacturer for several approved US DMFs. One of our major skills is the transfer of laboratory R&D (medchem) to a GMP process. We have FDA approved clean room facilities for parenteral APIs including cytotoxic materials.

Our analytical department including S2-laboratories for the necessary microbiological controls of the clean rooms and final products is approved by German Health authorities to release APIs and final dosage forms.

 

We are FDA approved without 483 issued. We developed the process and are the manufacturer for the fastest DMF approval of a cytostatic drug in FDA history (8 months). 
Chemcon is a privately held and independent company.

According to the company’s philosophy ChemCon works:

  • service-oriented
  • on the highest level of quality and safety
  • fast and reliable
  • under full protection of IP and customer knowledge
  • global

News:

ChemCon at BioFine 2008

This year’s BIOFINE in Freiburg was a home match for ChemCon. We presented our contract research and manufacturing services as an exhibitor, in collaboration with other partners from Biovalley (a regi

 
Quality Control - NMR - GMP

ChemCon´s Quality Control department is approved by the German Health Authorities (Regierungspräsidium), AMG (§ 14 Abs. 4 Nr. 3) to perform release testing of finished pharmaceuticals. This

 
APIs and Excipients: EU-GMP-Legislation

APIs and Excipients: EU-GMP-Legislation

On October 30th, 2005 a new EU legislation came into force that could be of utmost importance for the European manufacturers of active pharmaceutical ingredien