At 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
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.
U.S. Food and Drug Administration (U.S. FDA) inspections
In May, 2007 the U.S. Food and Drug Administration (FDA) approval of production and control of Xylazine, Detomidine hydrochloride and Oxytocin for compliance with U.S. quality standards was received, and these products were successfully registered on the U.S. drug market.
From 2011 the documentation of the active pharmaceutical ingredients Droperidol and Oxytocin for human use was under review by the FDA.
In March, 2013 JSC «Grindeks» active pharmaceutical production unit successfully passed two U.S. FDA inspections:
• Pre-approval FDA inspection, for entering the U.S. drug market and successful registration of Droperidol for human use and Xylazine hydrochloride for veterinary use.
• Follow-up inspection for previously registered veterinarian products - Oxytocin, Detomidine hydrochloride and Xylazine.
JSC «Grindeks» have received Establishment Inspection Report with the conclusion that API production unit corresponds to the Good Manufacturing Practice requirements, without any significant notes.
State Agency of Medicines of Latvia inspections
In June, 2013 and September, 2013 JSC «Grindeks» API production plant was inspected by State Agency of Medicines of Latvia.
Consequently, updated Good Manufacturing Practice certificates were obtained for 7 active pharmaceutical ingredients.