Pharmaceutical probiotics based on SF68®

Pharmaceutical probiotics based on SF68^® have a long history of safe use and proven efficacy in the prevention and treatment of intestinal disorders.

Cerbios has long-term customers receiving products based on Enterococcus faecium SF68^® (SF68^®) in different forms of standardized active ingredients, intermediates and finished products, such as hard gelatin capsules in glass bottles. Licensing opportunities for several markets are available.

USE

SF68^® is considered one of the best characterized probiotic active ingredients for the prevention and treatment of intestinal disorders. The pharmacological properties and safety profile of SF68^® have been extensively studied. The efficacy of SF68^® has been confirmed in many double blind clinical trials.

STRAIN

The strain (Enterococcus faecium NCIMB 10415) was isolated in a healthy newborn baby in Sweden in the sixties and selected for further use thanks to its favorable probiotic characteristics.

SYNONYMS

• S. faecium SF68^®

REGULATORY

Products based on SF68^® are available in many countries all over the world. In Europe, the most important products are registered and marketed under the trademark Bioflorin^® in Austria, Italy and Switzerland. Since 2008 Cerbios has been fully equipped to supply finished pharmaceutical products based on SF68^® in the form of hard gelatin capsules in glass bottles supported by a registration dossier in CTD format. Cerbios can guarantee a shelf life of 24 months at room temperature in climatic zone 2, for these finished products, following ICH guidelines.

INTELLECTUAL PROPERTY

SF68^® is a registered trademark owned by Cerbios-Pharma SA.

The strain deposit of Enterococcus faecium NCIMB 10415 in the National Collections of Industrial and Marine Bacteria in Aberdeen, Scotland, belongs to Cerbios-Pharma SA.