FDA approves the manufacture of new microbiome-based therapeutic VOWST™ at Recipharm site
Recipharm, a global contract development and manufacturing organization (CDMO), has announced today that its subsidiary, GenIbet Biopharmaceuticals, has been approved by the US Food and Drug Administration (FDA) as a manufacturing site of VOWST, a breakthrough orally administered fecal microbiota product for the prevention of Clostridioides difficile recurrent infection (CDI) in adults following antibacterial treatment for recurrent CDI. Recipharm will manufacture VOWST at its GenIbet site in Oeiras, Portugal on behalf of Seres Therapeutics. In the US, CDI has been classified as one