Evonik has received EXCiPACTTM certification for its EUDRAGIT® products produced in Darmstadt. The EXCiPACTTM certificate confirms that EUDRAGIT® is produced and sold in conformity with the EXCiPACTTM guidelines for good manufacturing practice (GMP).
Thanks to the EXCiPACTTM certification, Evonik's customers can rest assured that the EUDRAGIT® products are of the highest quality. "This certification shows that we are investing in product safety and cost-efficiency for our customers," notes Dr. Jean-Luc Herbeaux, head of the Health Care Business Line at Evonik. Evonik will ensure the consistent safety and quality of EUDRAGIT® products by undergoing recertification every three years and monitoring audits annually.
On an increasing basis, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are requiring that pharmaceutical manufacturers provide proof that the excipients used in their products are of GMP-compliant quality. This requires an increasing number of audits of excipient suppliers, which involves correspondingly high investments in cost and time. In these cases, EUDRAGIT® customers can use the audit report that is part of the EXCiPACTTM certification.
The EXCiPACTTM standard was developed with input from industry experts from all of the leading international pharmaceutical excipients manufacturers and from pharmaceutical companies. It complements the ISO 9001 norm and contains specific requirements for the manufacture of excipients.
Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms.
Evonik is active in over 100 countries around the world. In fiscal 2013 more than 33,500 employees generated sales of around €12.7 billion and an operating profit (adjusted EBITDA) of about €2.0 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.