Excipients – An utmost important substance class
High quality supply of Excipients with (no) or less variations – this is what Cfm Oskar Tropitzsch GmbH offers to it`s clients. Excipients are utmost substantial ingredients in drug products. The Excipients can be sometimes determinant for the activity of the final drug product. Even if this substance class is sometimes only seen as a by-product, they have a significant impact to the safety and efficacy of the final drug product.
Change Control, Quality Agreements, Supplier Qualification, Supplier Audits – all these important quality aspects of the big puzzle “Excipient Supply” are daily business for Cfm. To be able to answer fast, flexible, competent and trustful Cfm has a set of qualified mid-sized manufacturer who are experts in their specific field. They are mainly located in Europe but special know how is also available in USA, South America and Asia.
Beside the desired product, which fulfils customer’s specifications additional documents like ICH Q3D, Potential inorganic impurities, X-ray diffraction analysis, X-ray fluorescence analysis, residual solvents and many more are available.
Beginning of 2018 Cfm Oskar Tropitzsch GmbH was successfully inspected by the German Authorities. Cfm was one of the first companies within Bavaria, which complies to GDP (Good Distribution practice).
Over the past 20 years we were approached and challenged by many different customers with Excipients for different applications – many of these were client-specific manufactured excipients.