GMP chemical services

Synthesis and analysis of pharmaceutical ingredients and fine chemicals

Contract Development & Manufacturing

Analytical Services

Products

Quality & Regulatory

Quality made in Germany

Your reliable partner laboratory

In ChemCon you will find an internationally operating partner for the synthesis and analysis of pharmaceutical ingredients (APIs, GMP) and fine chemicals.

You are spot-on, if you are looking for a chemical substance (organic, inorganic, polymeric) in small to medium quantities. Examples are active pharmaceutical ingredients (APIs) in preclinical and clinical studies or for commercial chemical and pharmaceutical application.

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.

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.

Contract development and manufacturing organization (CDMO)

✧ Customized synthesis and process development ✧
✧ Organic and inorganic chemistry ✧
✧ Polymer Chemistry ✧
✧ Technical batches and GMP pilot batches ✧
✧ Active substances for clinical studies ✧
✧ Fine Chemicals ✧
✧ Cytotoxic, highly potent or BtMG regulated compounds ✧
✧ Close communication with chemists and process engineers ✧

Chemical Expertise

Small but important? Kilolab services availabe for commercial supply

Commercial contract manufacturing

We enable commercial routine production for an annual requirement of < 100 g to several 100 kg.

Your pharmaceutical ingredients are produced to GMP guidelines and your specifications for application in injectable, ophthalmic, oral, or topic formulations.

We also produce chemicals, starting materials, or reference standards upon inquiry.
Our analytics team takes care of qualification and release for you.

GMP production (APIs)

Chemical production

Chemical testing services

✧ Chemical characterization ✧
✧ Quality control ✧
✧ Impurity determination ✧
✧ Method development and validation ✧
✧ Release analysis ✧
✧ Stability studies ✧
✧ Reference standards ✧

Close, outcome-oriented communication: We also work with you on challenges, where routine testing is not sufficient.

What we can do for you

Quality confirmed by FDA and German authorities

Audits and GMP inspections

Since founding in 1997, ChemCon has been audited over 200 times, to the full satisfaction of the customers. We are looking back onto a long list of successful GMP inspections, most recently 2018 by the FDA (US Food and Drug Administration) and 2022 by German authorities (Regierungspräsidium Tübingen, EU GMP)

Inspection History