ChemCon's Expertise

ChemCon is a globally recognized partner for the development and manufacturing of active pharmaceutical ingredients (APIs) and fine chemicals. As a contract development and manufacturing organization (CDMO), ChemCon specializes in transferring research and development projects into fully cGMP-compliant manufacturing processes. Our company supplies customers worldwide with high-quality chemical products for clinical trials, commercial applications (including orphan drugs), pharmaceutical excipients, reference standards, and a broad range of other specialty chemicals. In addition to our custom manufacturing services, we also offer a selection of readily available products to meet immediate customer needs.

Our Expertise

ChemCon's strength lies in the combination of chemical expertise, regulatory knowledge, and flexible production capabilities. Our multidisciplinary experience enables us to meet the unique requirements of our customers. Our portfolio includes small-molecule organic APIs, inorganic compounds, polymers, as well as highly potent or controlled substances – all manufactured in full cGMP quality up to injection grade.

FDA-Inspected Manufacturing Facilities

Our state-of-the-art, FDA-inspected manufacturing facilities are specifically optimized for small to medium-scale production. With this focus, we enable efficient, high-quality, and flexible production tailored to our customers' needs. ChemCon has an outstanding inspection history with both the FDA and European health authorities.

Versatile Manufacturing Processes

Our production capabilities cover a wide range of chemical processes and technologies. Our expertise includes:

• Organic Synthesis: Production of small-molecule APIs, organometallics, and polymer-based compounds.

• Inorganic Chemistry: Manufacturing of metal salts, trace elements, radiolabeled compounds, and inorganic specialty chemicals.

• Polymeric Chemistry: Development and synthesis of functional polymers for pharmaceutical and industrial applications.

• Highly Potent Substances: Production of highly potent APIs (HPAPIs) under strict safety and cGMP conditions.

• Controlled Substances: Manufacturing and handling of APIs subject to stringent regulatory requirements.

Regulatory Support and Documentation

ChemCon offers extensive regulatory support to its customers. Our experienced team assists with the preparation and maintenance of:

• Registration dossiers (CMC documentation)

• Drug Master Files (DMFs)

• Manufacturing dossiers for clinical trials and market products

• Regulatory communication and audit support