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Commercial Manufacturing

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APIs and other cGMP substances in small to medium quantities

When your drug has successfully passed clinical trials, you have reached one of your biggest goals – but what if your annual demand remains below a quantity that CMOs are commonly willing to supply?

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ChemCon has found a way to bridge the gap between the profitable commercial production of small to medium quantities (grams to multiple 100 kilograms per year) and highest, GMP-compliant manufacturing standards. Cross-contamination is excluded with our innovative production strategy of mobile, dedicated equipment. In 2009 ChemCon won the STEP award for its dedicated equipment strategy. Again, our process engineers can give your dedicated equipment the finishing tailor-made touch required for an optimum production process.

For projects at the cGMP-stage we offer process validation according to ICH-guidelines to ensure full compliance of your project. 

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Step 3: Your commercial API

  • routine production up to several hundred kilograms per year
  • injectable, ophthalmic, oral, or topic grade
  • process validation
  • analytical services and quality control
  • comprehensive cGMP documentation
  • release by quality assurance
  • regulatory support
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