With niche pharmaceuticals in particular, it is essential that they offer tangible improvements in quality of life as well as safety and patient compliance. We are guided at every stage in development not only by commercial considerations, such as cost-efficient manufacturing, but above all by the therapeutic needs of patients. In order to create high-quality products that combine proven and innovative active substances with robust dosage forms, our top priority is strict adherence to all relevant quality guidelines.
Luye Pharma is one of Europe’s leading developers of transdermal therapeutic systems. As a full-service partner to the global pharmaceutical industry, we are experts in deploying high-end technologies and complying with international regulations. Our good manufacturing practice for pharmaceutical products is regularly certified by national and international authorities. Most recently, for example, we were inspected and approved by the U.S. Food and Drug Administration (FDA) in June 2015.
Our key to innovation is the open exchange of knowledge between the various departments involved across the process chain. By connecting these different competence areas, we have accumulated a wealth of solid experience over the past 20 years that we can now apply and expand through our own product development work as well as in contract projects. Where appropriate, we also draw on a trusted network of contract laboratories and consultants.
Our Miesbach plant is one of the largest manufacturing facilities for advanced transdermal therapeutic systems in Europe, with state-of-the-art laboratories for product and process development. Working with engineering firms and specialist machine builders, we develop customized equipment to meet the specific technical requirements of our expert staff. We also manufacture highly potent hormone products in a separate and strictly isolated facility.