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ChemCon GmbH

Booth number: 1501-7

www.chemcon.com
info@chemcon.com

About us

ChemCon is a contract development and manufacturing partner for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes. Customers worldwide use our services to source APIs for clinical trials and/or commercial applications (i.e. orphan diseases), excipients, reference standards, and all kinds of other high-quality specialty chemicals. Our FDA-inspected facilities 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 including trace elements, polymers, and highly potent or controlled substances – all in full cGMP quality up to injection grade. Comprehensive in-house analytics, stability studies, documentation, and regulatory support complete our services. ChemCon looks back on an outstanding inspection history both by the FDA and European health authorities.



Products and services

ChemCon is a contract development and manufacturing organization producing solely on demand. A flexible and transparent business model allows us to accustom proposal, project course, and the final product exactly to your needs. Our specialty is the transfer from R&D, via process validation and scale up, to fully cGMP-compliant manufacturing up to injection grade. We take on projects at any stage of development and are set up to serve you all the way to commercial API manufacturing, including documentation and regulatory support. Multidisciplinary competences of our experienced chemists include cGMP-compliant organic, inorganic, and polymer chemistry and the handling of highly potent and controlled substances. Our facilities are optimized for quantities between grams and hundreds of kilograms per year. This might be of particular relevance if you wish to source specialty compounds/excipients/APIs that are otherwise difficult to get hold of in the desired quality and quantity.
Contract API Manufacturing

Contract API Manufacturing

Drug substance manufacturing in small to medium quantities (g to a few 100kg per year) on demand to your specifications; Close communication; High-quality technical and fully cGMP-compliant material.

www.chemcon.com/en/services/gmp-services.html

Chemical Process Development (cGMP)

Chemical Process Development (cGMP)

Customized, fully cGMP-compliant process development for inorganic, organic or polymeric substances, including highly potent or controlled substances; flexible development concept and weekly updates

www.chemcon.com/en/services/gmp-services/chemical-de...

Quality Control + Assurance, Regulatory

Quality Control + Assurance, Regulatory

Full in-house quality control, quality assurance and regulatory support including stability programs, batch and release documentation, CoA, CoC, eCTD files.

www.chemcon.com/en/quality.html

News & Innovations

ChemCon wins CMO Leadership Award in five core categories  ChemCon GmbH, Contract Manufacturing Organization (CMO) for specialty drug substances and fine chemicals, has won awards in five categories of the 2018 CMO Leadership Awards: Capabilities, Compatibility, Expertise, Quality and Service in the groups Small Pharma and Overall.

Dr. Raphael Vogler, CEO & President: “Customers find in ChemCon a long-term partner to meet their individual sourcing needs. We are honored that our high-quality service is recognized by the CMO Leadership Awards.” ChemCon’s core business is the process development and manufacturing of active pharmaceutical ingredients (APIs) and other GMP-compliant substances in small to medium quantities. Customers benefit from interdisciplinary skills in inorganic, organic and polymer chemistry, including the expertise to handle highly potent and cytotoxic compounds. In-house quality control, quality assurance and regulatory support complete the portfolio.

Contacts

Address
ChemCon GmbH
Engesserstr. 4b
79108 Freiburg
Germany

Phone: +49 761 5597-0
Fax: +49 761 5597-449

Dr. Angelika Bull
Head of Marketing
Phone: +49 761 5597-0
info@chemcon.com


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