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Kilolab: GMP production of APIs

Contract manufacturing between 100g and a few 100kg p.a.

GMP lab: Production for clinical studies and commercial applications

When your drug has successfully passed clinical trials or registration, you have reached one of your biggest goals. ChemCon secures the reliable routine supply of your GMP-compliant ingredients to your specifications. If required, you may also contract the process development at our site.

If process development has already been completed, we ensure a seamless transfer to and validation at our site in Freiburg, Germany. Laboratories, cleanrooms and equipment are optimized for production campaigns in small to medium batches. Commercially we manufacture products for an annual demand of < 100 g to a few 100 kg.

Customers worldwide use ChemCon’s high-quality pharmaceutical ingredients for important specialty applications: a few examples include oncology, critical care, ophthalmology, dermatology, orphan diseases, and many more. We also produce advanced commercial excipients, diagnostics, or inorganic salts, if these are required to full GMP compliance (for example injection grade).

ChemCon’s production concept bridges 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.

A very special customer service is provided by our in-house technical team: Together with chemical engineers, our experienced technicians design or modify production equipment to the specific requirements of your process. This service can save time and money and makes the process safer.  Regulatory constraints are accounted for at any time.

More about Dedicated Equipment

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 GMP documentation
Release by quality assurance
Regulatory support
International filing of dossiers (eCTD)

Regulatory support

For projects in the GMP-phase we offer process validation according to ICH guidelines, to ensure the full compliance of your project.

ChemCon’s quality assurance team attends your project at any time. You will receive regulatory support all the way to the international filing of a dossier on your behalf, if required.

Regulatory Support