01 October 2019

Polpharma B2B is happy to announce that on 30th of August 2019, we obtained a new Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for API Zoledronic acid and currently we are the only company which have a CEP for this active pharmaceutical ingredient.

Our Team of Experts followed a new EDQM regulation of electronic submission for Certificate of Suitability (CEP) application by providing belowlist of documents:

•    a completed application form which includes your invoicing details
•    a dossier in CTD format written in one of the two official languages of the Council of Europe (preferably in English),
•    a single copy of the Quality Overall Summary (QOS).

Thank you very much to the whole team who were involved in this success!

zoledronic acid

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