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, injectable 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, including highly potent or controlled substances – all in full cGMP quality. Comprehensive in-house analytics, stability studies, documentation, and regulatory support complete our services. ChemCon looks back on an outstanding inspection history by both the FDA and European health authorities.
ChemCon is a CDMO producing on demand. A flexible and transparent business model allows us to accustom proposal, project course, and the final product exactly to your needs. Our core expertise is the transfer from R&D, via process validation and scale up, to fully cGMP-compliant manufacturing (injectable, ophthalmic, oral, topic grade) for quantities between grams and a few hundred kilograms per year.
You will also find selected commercial specialty APIs and GMP salts at ChemCon. If your product is not on the list, please contact us. Our experienced chemists will offer you tailor-made custom development and manufacturing of your specialty API.
If you are looking for ICH-compliant quality control, GMP validation, release analysis, impurity determination, and reference standards, ChemCon’s analytics team takes care of your inquiries. We also support you with any other analytical questions where routine testing might hit its limits.
Some of ChemCons GMP products (injectable, ophthalmic, oral, topic grade):
- acetylcholine chloride
- arsenic trioxide
- sodium tetradecylsulfate (STS, STDS)
- chromium(III) chloride
- copper(II) chloride
- iron(II) chloride
- manganses(II) chloride
- sodium selenite
- sodium molybdate(VI)
- zink chloride
- Chemical synthesis and process development of drug substances
- 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
Polymers used in medical applications receive increasing regulatory attention. With customized offers we match material specifications exactly to your needs and regulatory GMP requirements.
GMP Polymer projects at ChemCon include:
- synthetic polymers (e.g. PEI, PEG derivatives)
- derivatization and purification of natural polymers
Our polymer expertise is complemented in-house with state-of-the-art techniques, such as ultrafiltration, DOSY NMR spectroscopy, GPC, or rheometry.
Head of Business Development
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