GMP certification for hydrogen peroxide
- PERSYNT® as active substance in health care products
- Certification over the entire production process in Weißenstein
- Listing in EudraGMDP
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 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.
Brenntag Holding GmbH exclusively distributes the products for most parts of Europe.
About Resource Efficiency
The Resource Efficiency segment is led by Evonik Resource Efficiency GmbH and supplies high performance materials for environmentally friendly as well as energy-efficient systems to the automotive, paints & coatings, adhesives, construction, and many other industries. This segment employed about 7,800 employees, and generated sales of around €4 billion in 2014.
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. In its business activities, which are spread across three segments—Nutrition & Care, Resource Efficiency, and Performance Materials—Evonik’s greatest resources are its innovative prowess and integrated technology platforms. In 2014, over 33,000 employees generated sales of around €12.9 billion and an operating profit (adjusted EBITDA) of about €1.9 billion.
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.