EudraGMDP API reg: sukls334436/2021
Use: Active Pharmaceutical Ingredient for manufacturing magistral formulas and use in clinical trials.
Origin: isolated from an extract of Cannabis sativa L. of GACP status
The individual tested parameters and limits are in accordance with the requirements of the German Drug Codex monograph (DAC/NRF 2020/2, C – 052), draft EDQM monograph (PA/PH/Exp. 11/T (21) 50 ANP) and general chapters of the European Pharmacopoeia (Ph. Eur.).
The product is manufactured, analysed, handled and stored in accordance with Good Manufacturing Practice (GMP) and as outlined in the International Conference on Harmonized „ICH Q7 guideline on Good Manufacturing Practice for Active Pharmaceutical Ingredients".
Stability data: ICH Zone II, IVb
Made in the EU. Made from EU hemp.
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