Highest International Standard
At our European production site in Pfaffenhofen (Germany), state-of-the art facilities ensure a consistently high production quality. Regular audits by national and international authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) confirm this.
Pfaffenhofen contributes significantly to our global production capacity. Pharmaceuticals are not only manufactured, but also developed here. This includes the entire Olmesartan product range and Edoxaban. More than 100 million blisters and more than two billion tablets are produced in the pharmaceutical production each year.
Pfaffenhofen's activities comprise biotechnology API (active pharmaceutial ingredients) manufacturing and the production of solid pharmaceutical products (tablets and film-coated tablets). From here they are exported as bulk or finished packs to patients to more than 50 countries. This will soon also be the case for medication from the oncology field. Our plant is prepared in terms of infrastructure as innovation and modernisation go hand-in-hand.
Pfaffenhofen also plays a key role in pharmaceutical development and globally assumes a leading role for an increasingly large number of galenic research projects. The goal of pharmaceutical development is to develop applicable medicines, such as tablets, from active ingredients provided by our Research & Development (R&D) Division. The drug product has to be designed to meet the patient´s needs, to fulfil the clinical requirements and to ensure quality. Furthermore, the manufacturing process suitable for producing the drug product on a commercial scale has to be developed, scaled up and transferred to Production. Last but not least, Pharmaceutical Development is responsible for the quality part of dossiers submitted to the regulatory authorities. This time-consuming and diligent approach is a vital prerequisite to making high-quality and safe pharmaceutical products available to patients worldwide.