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Esomeprazole Sodium - Written Confirmation for Exportation to EU

We are happy to announce that Jiangsu Zhongbang obtained the Written Confirmation for active substances exported to EU which includes Telmisartan and Esomeprazole Sodium.

Background information:
As per the EU Directive, aimed at preventing falsified medicinal products from entering EU from other countries, the APIs meant for medicinal products for human use would require WC certificate for each API unit by the enforcement authorities of the exporting countries confirming compliance with GMP standards or rules 'equivalent to the rules applied in the EU', such as WHO GMP, 'International Conference for Harmonization' Q7 (ICH Q7), etc. The EU Directive will come into effect from July 2 2013.

On a:Esomeprazole Magnesium- CEP/COS from EDQM    Next: Jiangsu Province GMP Approval from CPDE
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