ChemCon GmbH

About ChemCon GmbH

In ChemCon you will find an internationally operating partner for the synthesis and analysis of pharmaceutical ingredients (APIs, GMP) and fine chemicals, based in Germany.
You are spot-on, if you are looking for a chemical substance or a fully GMP-compliant API, i.e. for preclinical and clinical studies or for commercial application. Customers worldwide use our services to source APIs for clinical trials, registration and/or commercial applications (i.e., orphan diseases, oncology, or emergency care), excipients, injectable trace element salts, diagnostics, delivery agents, or reference standards.
ChemCon’s FDA-inspected facilities are optimized for the production of small to medium quantities of organic small-molecules, inorganic salts and complexes or polymers, all to full GMP injection grade, if required.
Our analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries.
On top of our chemical services, you will also find selected products in ChemCon’s portfolio.
Quality assurance and regulatory consulting completes comprehensive GMP-compliant production and analysis, validation and documentation.

  • DE
  • 2015
    On CPhI since
  • 100 - 249
    Employees
Manufacturer/Innovator
Contact info

Products from ChemCon GmbH

  • GMP API Manufacturing

    Product GMP API Manufacturing

    Process development and manufacturing services represent a core part of our business. We utilise accumulated know-how and advanced technologies and provide everything that you desire from a high-quality API supplier. ChemCon is also experienced in manufacturing regulated substances and has the flexibility required to adjust the manufacturing schedule to accommodate urgent production needs. Besides the synthesis process itself, we offer complete supporting services: Continuous assessment of processes, analytical method development and validation, synthesis, identification and qualification of reference standards and impurities, stability studies that conform to ICH and EU-GMP guidelines, process validation, comprehensive regulatory support, safety/hazard assessment. ChemCon produces APIs for parenteral use under full microbiological control.
  • Analytical Services

    Product Analytical Services

    ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries. Close, outcome-oriented communication is the key to a successful partnership: We also work with you on challenges, where routine testing is not sufficient. Services include: NMR, ICP–MS, ICP–OES, HPLC, GC, IC, GPC, FT–IR, UV–vis, Photospectrometry, Rheometry, Titration, KF, MP, TOC, LOD, ROI, Polarimetry, Microbiological tests, Microscopy, RC1.
  • Chemical Development

    Product Chemical Development

    Process development and manufacturing services represent a core part of ChemCon’s business. Multidisciplinary competences of experienced chemists include cGMP-compliant organic, inorganic, and polymer chemistry and the handling of highly potent and controlled substances. Production facilities are optimized for quantities between grams and hundreds of kilograms per year. ChemCon’s CDMO services include: Synthesis and process development, technical batches and GMP validation batches, contract manufacturing of pharmaceutical ingredients. Your pharmaceutical ingredients are produced to GMP guidelines and your specifications for application in injectable, ophthalmic, oral or topic formulations. Commercial routine production is available for an annual requirement of < 100 g to several 100 kg.
  • Fine Chemicals Manufacturing

    Product Fine Chemicals Manufacturing

    ChemCon manufactures and markets valuable chemicals of high purity on demand, capitalizing on our experience in complex multi-step synthesis chemistry. It synthesizes organic and inorganic small molecules in the scale ranging from milligram to multi kilogram. Its core strengths in this field: Expert synthetic knowledge, experienced and motivated chemists, proven track record of reliability and high quality.
  • GMP HPAPI and Controlled Substances Manufacturing

    Product GMP HPAPI and Controlled Substances Manufacturing

    Handling of cytotoxic and other highly active substances requires adequate facilities and enclosures as well as a lot of experience. ChemCon offers high-containment operations for the manufacturing of cytotoxic substances and highly potent active pharmaceutical ingredients (HPAPIs). Our services include HPAPI manufacturing under cGMP conditions, utilizing cutting-edge technology, comprehensive product experience, and rigid training procedures. ChemCon manufactures HPAPIs in gram to kilogram quantities. ChemCon meets all requirements to handle controlled substances according to the German Narcotics Law (Betäubungsmittelgesetz, BtMG). Rigorous internal control systems are in place to limit access to the premises (safes). Starting materials, intermediates, pharmaceutical ingredients or reference standards: You can rely on a safe and legal development and production of your compound at ChemCon.

ChemCon GmbH Resources