The manufacturer BENEO, member of the Südzucker Group, recently announced that the Pharmaceutical and Medical Devices Agency (PMDA) in Japan has granted the first license for the manufacture and distribution of a pharmaceutical product utilizing the benefits of galenIQ. Having already been approved in the US and Europe, the granted license is seen as a reference approval for galenIQ in Japan.

“We are delighted to be present with galenIQ in one of the most important markets for the pharmaceutical business,” said Bodo Fritzsching, Head of Sales & Technical Services PHARMA. “The approval is a considerable step forward for galenIQ since its launch in 2005, and confirmation of the product’s technological and physiological properties. Because manufacturers located in Japan as well as global manufacturers with international drug formulations can now benefit from galenIQ, we are confident that more market products will follow.”

galenIQ (pharmaceutical grade isomalt) is available in different grades. All grades are characterized by their very low hygroscopicity, excellent chemical and physical stability, as well as their technological benefits. The multifunctional excipient especially facilitates the development and formulation of specific solid-dosage forms, such as tablets, sachets, capsules, coatings, or lozenges. galenIQ is a white, odorless, water-soluble, crystalline substance of non-animal origin and GMO-free. Furthermore, it shows a low glycemic response and is non-cariogenic.

The multifunctional excipient combines the advantages of other well-known fillers and binders. Manufactured in different grades, it is used in a very wide range of different solid dosage forms. The galenIQ range includes grades 720 and 721, which are excellent filler/binders for direct compression and powder mixture applications, and the 800 series, which offers special ground grades for wet granulation, compaction, and other agglomeration processes. Besides its application in granulation, galenIQ 801 is used as a co-polymer in film-coatings to improve film adherence and reduce coating time. The 900 series is highly suitable for capsule fillings, sachets, sugar-free coatings, and high-boiled lozenges.

galenIQ is listed in the US FDA’s inactive ingredient database under its generic name Isomalt. It complies with the isomalt monographs of the current Ph Eur, BP, and USP-NF. BENEO-Palatinit is a member of the International Pharmaceutical Excipients Council, and produces galenIQ under cGMP conditions for pharmaceutical excipients.