Production of sodium selenite pentahydrate
Innovation leader in the production of trace elements

Production of sodium selenite pentahydrate based on a specially developed production process

CEP certification for three active ingredients of biosyn Arzneimittel GmbH

For more than a decade, biosyn Arzneimittel GmbH has been an innovation leader in the production of sterile and high-quality trace element compounds under clean room conditions. Since 2009, the medium-sized company headquartered in Fellbach has been in a position of producing the active ingredient sodium selenite pentahydrate – the base element for all selenium products of the company – to the internationally mandated cGMP quality standards from their location in Germany. An essential foundation of this achievement is a production process developed specifically by biosyn. Patents have been granted for this process in Europe, the United States, and Canada, as well as in other countries. It is supported by years of experience and the inventive spirit of the biosyn staff. In addition to sodium selenite pentahydrate, the company also produces sodium selenite and sodium molybdate dihydrate

Several active ingredients certified with CEP

CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia) have been granted for three active ingredients from biosyn Arzneimittel GmbH. This certificate confirms that the active ingredient meets the quality described in the corresponding monograph of the European Pharmacopoeia. Hence, such a certificate establishes the immediate reference to the pharmacopoeia monograph.
If this active ingredient is used by a drug manufacturer in the course of the approval procedure as a component of a medicinal product, then the reference to the corresponding CEP certification is sufficient for the authorities. The issuing authority is the European Directorate for the Quality of Medicines (EDQM), with its offices being in Strasbourg.
The CEPs have been available since 2018 for anhydrous sodium selenite (R0-CEP 2017-197-Rev 01), since 2019 for sodium selenite pentahydrate (R0-CEP 2018-212-Rev 02), and since 2020 for sodium molybdate dihydrate (R0-CEP 2019-031-Rev 01). Other important trace elements for the production of injectable liquid medicinal products of cGMP quality – made in Germany – were established at biosyn.
Innovation leadership in the production of trace elements.
biosyn Arzneimittel GmbH

World market leader in high-dose
Selenium Injections

biosyn Arzneimittel GmbH is a pharmaceutical and biotech company based in Fellbach. It specializes in trace elements, is the world market leader in high-dose selenium injections, is the developer and operator of two globally unique cGMP active ingredient production facilities, and is also active in the biotech sector with a glycoprotein isolated from Megathura crenulata, a marine snail found in California. 70 percent of sales are generated outside Germany - in 27 countries around the world.

Active in the fields of intensive care, oncology and endocrinology, biosyn and its products are a partner for clinics and physicians in private practice, as well as for naturopathic doctors and alternative practitioners. Research and development are just as much a part of the employees' responsibilities as the processing of current medical-scientific literature and modern online marketing. The medium-sized family business attaches great importance to an open, committed and customer-oriented corporate culture.