Besides our API portfolio, we are offering numerous Excipients. We will support you in performing individual risk assessments, e.g by providing required documents and data like elemental impurities according to ICH Q3D, statements on residual solvents, BSE/TSE, GMO or allergens.
* anhydrous form
Also with respect to our excipient portfolio, Jungbunzlauer is constantly expanding its portfolio according to the customers and market’s needs. Please get in contact with us to get further information or to get a personal quote for one of our Excipients.
The quality of our ingredients has a profound impact on the quality of your end products. Moreover, consistent high quality and purity of our products minimize the risk of quality deficiencies in your end products and thus minimize the risk of product liabilities as well as of brand and image damages. This is why we strive to the zero default principle - which applies not only to our products, it starts from manufacturing, packaging and logistics and includes the supply chain.
The International Pharmaceutical Excipients Council Europe (IPEC) standards for excipients have been established in our plants in Pernhofen, Austria for all excipients.
Fulfilment of the requirements of the ISO9001 Quality Management Standards is the logical result of Jungbunzlauer’s comprehensive quality commitment and the company’s plants have been certified.
Risk assessment concept is established in our plants in Pernhofen, Austria and Ladenburg, Germany.