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- 04/15/2019

GMP for polymers and metal salts and complexes – meet ChemCon, FDA-inspected German CDMO

Chimica Oggi-Chemistry Today

In ChemCon, you find an internationally operating partner for the high-quality chemical synthesis and analysis of pharmaceutical ingredients and fine chemicals. Our project leaders meet you with broad chemical expertise in organic, inorganic and polymer chemistry.

  • Organic small molecule APIs
  • Inorganic salts and complexes
  • Organometallic compounds
  • Synthetic polymers
  • Derivatives of natural compounds

Today, we would like to draw your special attention to the inorganic substances and polymers. We note a rising demand for cGMP-compliant excipients or other substances that previously did not require full cGMP documentation. In particular, for parenteral application such substances are receive increasing attention from regulatory authorities. Examples vary from simple metal salts for intravenous application to advanced polymeric transfection agents.

ChemCon has a long tradition in the manufacturing of (bio)inorganic APIs, which goes back to the roots of the company’s founding in 1997. More than twenty years later, inorganic synthesis at ChemCon comprises the whole spectrum from simple salts to advanced complexes. For a number of metal salts (GMP, injection grade), ChemCon has now submitted dossiers in several countries worldwide. In recent years, ChemCon also acquired a number of projects to synthesize polymers to full GMP compliance.

Customers worldwide use the services of the FDA-inspected CDMO to source or analyze APIs for clinical trials, registration and commercial applications. This comprises both new chemical entities and generic substances. ChemCon’s production facilities in Germany are optimized for niche production campaigns in small to medium quantities (grams to a few 100 kilograms per year commercial routine supply.) Broad expertise with a large number of very individual and very different projects allows the CDMO to respond flexibly to customers’ individual requirements and to current regulatory trends and changes.

ChemCon’s analytics team takes care of inquiries for ICH-compliant quality control, GMP validation, release analysis, impurity determination, reference standards or answers to other analytical queries.

On top of chemical services, you will also find selected products in ChemCon’s portfolio.

 

The company looks back on an outstanding inspection history by both the FDA and European health authorities. The most recent and flawless FDA inspection took place in October 2018.

 

www.chemcon.com


 

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