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Evonik Achieves GMP Certification

Relates to pharmaceutical-grade hydrogen peroxide made at its Weissenstein facility

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Evonik Resource Efficiency GmbH has obtained good manufacturing practice (GMP) certification and manufacturer’s authorization for Persynt (pharmaceutical-grade hydrogen peroxide) in its Weissenstein, Austria, production facility. It has GMP over the entire production process, right from the starting substances oxygen and hydrogen. Evonik is now also listed in EudraGMDP, a database, which covers GMP-certified manufacturers of active substances.  

The GMP certificate authorizes Evonik Resource Efficiency to produce, test and market hydrogen peroxide as an active substance. The specialty hydrogen peroxide products Persynt 300 GMP and Persynt 350 GMP can now be sold to the health care industry as active substances for dental or wound disinfection, wound cleaning, mouthwashes, and preparation of topical solutions.   

As a next step Evonik just started the process of applying for a CEP (Certificate of Suitability of Monographs of the European Pharmacopoeia). The role of a CEP is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. Active pharmaceutical ingredients for which a Certificate of Suitability has been granted are suitable for use in medicinal products. A CEP eases the marketing authorization for Evonik’s customers.    

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