ChemCon GmbH
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 can look back on an outstanding inspection history both by the FDA and European health authorities.
Address
Engesserstr. 4b
79108 Freiburg im Breisgau
Germany
E-mail: info@chemcon.com
Phone: +49 761 55970
Internet: www.chemcon.com
Contact person:
Products & Services
Beside the CDMO business, ChemCon is a service provider for exclusive and generic active pharmaceutical ingredients (APIs) and new chemical entities (NCEs) for a variety of applications.
Our focus lies on the production of small to medium quantities of high quality specialty substances.
ChemCon’s APIs are released to current monographs or to defined specifications, following validated internal methods. Quotes and release protocols can be customized to your needs for quantities and specifications for international markets.
The list of GMP products includes organic and inorganic niche active ingredients as well as GMP-compliant inorganic metal salts or polymers.
Histamine dihydrochloride [56-92-8]
ChemCon has developed a specially designed process to manufacture GMP-compliant histamine dihydrochloride for topical applications. The company was successfully inspected for GMP compliance of this product by the German authorities (Regierungspräsidium Tübingen) four times since 2013. The specifications are set according to the current Ph. Eur. monograph. Dossiers were submitted in several countries and can be filed for additional countries depending on your marketing needs.
Nicardipine hydrochloride [54527-84-3]
ChemCon has developed a specially designed process to manufacture GMP-compliant nicardipine hydrochloride for injectable applications. The specifications are set according to the current USP monograph for nicardipine hydrochloride. The company was successfully inspected for GMP compliance of this product by German authorities (Regierungspräsidium Tübingen) in 2019 and 2022. A DMF or ASMF can be filed on request within short time. Please let us know which markets you are considering.
Nitroprusside dihydrate, sodium [13755-38-9]
ChemCon developed a specially designed process to manufacture GMP-compliant sodium nitroprusside dihydrate for injectable applications. The specifications are set according to the current USP monograph for sodium nitroprusside dehydrate API. ChemCon was successfully inspected for GMP compliance of this product by German authorities (Regierungspräsidium Tübingen) and the FDA. ChemCon successfully filed a US DMF in 2014.
Methylene blue [122965-43-9]
ChemCon developed a specially designed process to manufacture GMP-compliant Methylene Blue (Methylthioninium chloride) Injection Grade for parenteral applications. The product is manufactured under strict GMP conditions to meet the highest requirements for purity, process control, documentation, and regulatory compliance required for injectable APIs. ChemCon was successfully inspected for GMP compliance by the German authorities (Regierungspräsidium Tübingen) and the FDA.