ChemCon GmbH

ChemCon GmbH

Contract development and manufacturing partner located in Germany for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes.

About the plant

ChemCon, located in Freiburg, Germany, is your contract development and manufacturing partner for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. Our inspected facilities (inspected by FDA and German authorities, 16-times) are optimized for the production of small to medium quantities. With multidisciplinary expertise, we can meet your individual demands for small-molecule organic APIs, inorganic compounds and polymers. Comprehensive in-house analytics, stability studies (ICH-compliant), documentation, and regulatory support complete our services.

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Certifications

• EMA (EU GMP)
• FDA (cGMP)
• ECOVADIS

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Activity

• CHEMICAL-SYNTHETIC, RSM (Raw Starting Materials), Intermediates, Fine Chemicals, API (Active Pharmaceutical Ingredients), Excipients, Radiopharmaceuticals manufacturing

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Features

• Uses: Commercial (Phase IV), Human
• Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
• DEA: Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
• BSL: 1, 2
• Therapeutic areas: (C) Cardiovascular system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (V09-10) Radiopharmaceuticals
• Markets: COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), TGA (Australia), MFDS (South Korea)

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Batch Size / Reactor

• Small, Medium, 1 - 10 L, 10-100 L, 100 - 1,000 L, 1,000 - 2,000 L, 2,000 - 5,000 L, 5,000 - 10,000 L, > 10,000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, R&D, Process development, Process optimization, Process validation, Stability studies execution, ICH Stability studies, Tech transfer, Lyophilization, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of product, Analytical methods transfer, Batch certification / release, GMP documentation, CMC regulatory support, Solid form selection

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