We are delighted to announce that German authorities certified ChemCon as GMP compliant once more. German health authorities (Regierungspräsidium) have inspected ChemCon twelve times, first in 2003. ChemCon passed all inspections, nine of which regarded GMP compliance.
From October 22 – 24, 2019, members of the Regierungspräsidium Tübingen inspected 19 API products produced at ChemCon’s site in Freiburg, Germany. The local German authorities are in place to control GMP compliance according to the guidelines of the European Medicines Agency (EMA). All products passed as fully GMP-compliant. The authorities issued according certificates in March 2020.
Reliability is a key factor in the pharmaceutical supply chain. We are proud to show, once more, that ChemCon’s customers can trust in reliably high-quality supply of fully GMP compliant APIs. In more than 20 years company history, ChemCon has never received a critical observation, neither by the U.S. Food and Drug Administration (FDA) nor by German authorities.
The most recent FDA inspection took place at the end of 2018.
For ChemCon’s complete inspection history, please see here.
