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2020-10-26 05:41:30

«Grindeks» has introduced a new active pharmaceutical ingredient

By Editor. 28.08.2009

JSC «Grindeks» informs that it has introduced the new active pharmaceutical ingredient (API) ursodeoxycholic acid (UDCA), which is used for production of final dosage forms in the treatment of hepatic and gallstone diseases.  

«Grindeks» carried out the first deliveries of pilot series to German pharmaceutical company "Marenis Pharma" already last year. After positive quality assessment a multi-degree and long-term cooperation agreement was concluded with «Grindeks».

Chairman of the Board of «Grindeks» Jānis Romanovskis: "Research, development, manufacturing and sales of active pharmaceutical ingredients is one of «Grindeks» business fields, which we have purposefully developed over the last years. Although we are small company in comparison with the global pharmaceutical concerns, the introduction of this product confirms, that we are serious player and reliable partner. The concluded agreement will increase our competitiveness, as well as promote increase of exports."

Introduction of the UDCA product will diversify business activity of «Grindeks», extend a product portfolio, as well as development opportunities within completely new medical therapeutic group for the company - gastroenterologal diseases.

In accordance with the concluded agreement, 30t of UDCA substance will be delivered by «Grindeks» in 2011. In general, it will considerably extend and even double the API's business of «Grindeks». Three first deliveries of industrial manufacturing series for the further development of final dosage form are already supplied.

Director of «Grindeks» Active Pharmaceutical Ingredients Business unit Andris Jegorovs: "Development and manufacturing of the UDCA is complicated and time-consuming, but our highly experienced and professional specialists empowered by advanced technologies can ensure introduction of high value-added products. It is a new source of profit and international recognition for the company."

In order to ensure regular development and manufacturing of the UDCA, «Grindeks» has started construction of a new manufacturing unit with investment of almost 6 million lats. The construction will be completed in 1.5 - 2 years. The production area will provide 35 new work places.

In 2008, the turnover of «Grindeks» APIs reached 5.1 million lats. «Grindeks» regularly manufactures 16 types of complicated APIs created in multi-stage synthesis. The main products are mildronate, ftorafur (tegafur), zopiclone, oxytocin and the group of veterinary APIs. Strengthening of the existing market positions and acquiring new positions are facilitated by development and production in accordance with the standard of GLP (Good laboratory practice) and GMP (Good manufacturing practice), as well as other international recognitions of the compliance to international quality standards.