Regulatory Status

Last Updated on Mittwoch, 2 Dezember 2015 11:49 Written by admin Samstag, 8 Dezember 2012 02:59

Routine inspections by the German Health Authorities covering the EU
Last inspection was in March 2015

Inspections by foreign Regulatory Authorities

ANVISA (Brazil)
Last inspection was in 2013

Food and Drug Administration (USA)
Last inspection was in May 2015

 

Quality Control

The Quality Control Organization is equipped with state of the art analytical instruments and has dedicated labs to handle high active substances.

Storage areas for stability samples are set up according to the latest ICH Regulations.

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