ChemCon is a GMP-compliant contract development and manufacturing organization (CDMO) and provider of analytical testing services.
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, provocation substances, dietary trace elements, diagnostics, delivery agents, or reference standards. 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 salts and complexes, polymers, and highly potent or controlled substances – all in full cGMP quality (including parenteral 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.
ChemCon is a CDMO 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 (injectable, ophthalmic, oral, topic grade). 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.
ChemCon’s analytics team takes care of your inquiries if you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, and reference standards.
We also support you with any other analytical questions where routine testing might hit its limits.
- Chemical synthesis and process development
- Technical batches and GMP validation batches
- Contract manufacturing of pharmaceutical ingredients (GMP-compliant) and fine chemicals
- Commercial routine production for an annual requirement of < 100 g to several 100 kg
- Equipment and expertise to handle cytotoxic, highly potent or controlled substances
- Chemical characterization
- Quality control
- Impurity determination
- Method development and validation
- Release analysis
- Stability studies
- Reference standards
Some of ChemCons GMP (injectable, ophthalmic, oral, topic grade) products:
- acetylcholine chloride
- anagrelide, arsenic trioxide
- methylene blue
- sodium nitroprusside
- sodium tetradecylsulfate
- several inorganic salts
- derivatives of polyethyleneglycol, polyethyleneimine, hyaluronic acid