SalesAt the top of the offer of active pharmaceutical ingredients (API) of «Grindeks» in the domestic and foreign sales sphere are ftorafur, zopiclone, oxytocin and veterinary products - detomidine, medetomidine and atipamezole. Produced substances are marketed in more than 40 countries around the world, of which the most important sales markets are Germany, the Netherlands, Japan, the USA, Australia, Pakistan and India. The market position strengthening and of new markets is promote the acquisition of the Certificate of Suitability (COS) for oxytocin in 2004, for zopiclone in 2005, for flecainide in 2009, and the veterinary product - xylazine hydrochloride - in 2010, facilitates the registration of products in all countries, where the European Pharmacopoeia is in force. «Grindeks» with its registration documentation developed for active pharmaceutical ingredients successfully participate in registration procedures for final dosage forms, done by clients. Detomidine is the first of the new active pharmaceutical ingredient, manufactured by «Grindeks», for which Mutual Recognition Procedure (Mutual Recognition Procedure (MRP)) was successfully completed in 19 European countries in 2006. In 22 EU countries medetomidine was registered in 2007. In 23 EU countries in the decentralized registration procedure atipamezole was registered in 2008, while pimobendane was registered in 17 EU countries in 2011. In May of 2007, the U.S. Food and Drug Administration (FDA) approval of production and control of xylazine and detomodine for compliance with U.S. quality standards was received, and both of these products are successfully registered on the U.S. drug market. Currently, the documentation of the active pharmaceutical ingredients droperidol and oxytocin for use in humans is under review by the FDA.
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