The active pharmaceutical ingredient of UDCA was included in the Grindeks product portfolio in 2011, when separate manufacturing unit for its production was built. In 2014 the export volume of the active pharmaceutical ingredient of UDCA accounted for more than 0.5 million euro. The substance is now being exported to four countries – Russia, Japan, France and Malta.
In 2013 highly structured Ursodeoxycholic acid world market underwent significant changes, which resulted in considerably decreased accessibility to the necessary raw material, that limited manufacturers’, including Grindeks, options to produce UDCA in the quantity required. Taking it into account, Grindeks immediately started determined restructuring of this business, beginning the development of the final dosage form (capsule), as well as developing contract manufacturing. The registration of the final dosage form was successfully finished in the first quarter of this year.
The Chairman of the Board of the JSC Grindeks Mr. Juris Bundulis emphasizes that with implementing the final dosage form of UDCA Grindeks strengthens its position as a vertically integrated pharmaceutical company, which provides manufacturing of active pharmaceutical ingredients as well as final dosage forms: “Grindeks is determinedly expanding its offer in the gastrointestinal tract and metabolism drug therapeutic group. We are not going to stop – accordingly to the development plan for this drug therapeutic group, we are going to continue the registration of the UDCA product in other countries, including Europe, as well as we are going to introduce new products in this therapeutic group in the future.”
The demand for UDCA preparation is increasing, because growing number of people are being diagnosed with bile formation and secretion disorders. One third of the world’s population is diagnosed with hepato-biliary way diseases. 25% of the population aged over 60 years suffers from urolithiasis (presence of stones in the urinary tract).
UDCA indications are: cholesterol gallstone disease, bile reflux gastritis, symptomatic treatment of primary biliary cirrhosis, symptomatic treatment of hepatitis of different genesis, primary sclerosing cholangitis, cystic fibrosis (mucoviscidosis), non-alcoholic steatohepatitis, alcoholic liver disease, biliary dyskinesia.