Several API manufacturers in China, India and Brazil found out of GMP compliance

GMP non compliance identified during the inspection of API manufacturing sites or due to the fact that a manufacturing site has not declared the willingness to be inspected caused again a number of consequences.

In the past weeks and months a number of manufacturers from China, India and Brazil were informed by EDQM that their CEP will be suspended or withdrawn. This information has also been published by EDQM and several EU Authorities in order to inform the manufacturer of the medicinal products who have been purchasing APIs from those API manufacturers. The Danish authority for example states: “If the EDQM withdraws or suspends a CEP, the marketing authorisation holder must take the necessary measures to ensure that active substances from the concerned active substance manufacturer are not used, either permanently or for a defined period. If any medicines on the market contain this active substance from the concerned active substance manufacturer, the marketing authorisation holder must report the product defect.

The suspension or withdrawal of CEPs has therefore immediate consequences for companies who purchase APIs from these manufacturing facilities.

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP):

Source: www.edqm.eu

Please note that all reports about non-compliance issues or regulatory actions (such as FDA Warning Letters, CEP withdrawls, etc.) are taken with utmost carefullness from the respective regulatory website. Individuals should check the current situation of any company they wish to do business with to make sure that they have the most up-to-date information.