As a leading manufacturer of essential oils that are suitable as active pharmaceutical ingredients (API), we ensure compliance with the highest standards when it concerns consumer protection and product safety for use in pharmaceuticals. We are producing for our customers within the scope of our European GMP certificate under GMP II active ingredients and are offering under our EGST-Line Eucalyptus oil GMP, Turpentine oil GMP, Peppermint oil GMP as well as several others. Because of our manufacturing license according to § 13 AMG we are able to produce high-quality pharmaceutical intermediate products under GMP I. For the approval process, product registration and to facilitate a fast market launch of our customers’ products, we offer complete ASMF solutions and documentation packages, as well as stability tests according to ICH Guidelines.
GMP Manufacturing of Active Ingredients
Drug safety at the highest level: Active pharmaceutical ingredients (API) used in the production of pharmaceuticals must be manufactured in compliance with the Good Manufacturing Practice (GMP) principles. FREY&LAU fulfills all applicable requirements with a corresponding quality assurance system and is accordingly GMP-certified by the responsible authority. We are in possession of the manufacturing authorization for pharmaceuticals registered under the Eudralex Database, pursuant to § 13 AMG, which includes the authorization for further treatment of pharmaceutical intermediate products. Our GMP certificate enables us for essential oils and their constituents, to distil them, and to implement any additionally required steps necessary for the production and sale of essential oils as active pharmaceutical ingredients (API). Our product range currently encompasses 15 essential oils in API Quality.
The simple route to register pharmaceutical products: We want to effectively and efficiently support our partners through the drug approval process. To this end, we offer comprehensive packages of qualified documents for seamless and transparent documentation. For the approval of essential oils as active ingredient components in pharmaceuticals, we create corresponding dossiers in our approval department for all active ingredient products in accordance with the European Drug Master File Procedure (ASMF). This allows us to meet the continuously growing challenges of European legislation. Moreover, we advise our customers extensively in direct contact with the responsible approval authorities, thus supporting numerous approval proceedings every year, all across Europe.