JSC Grindeks is pleased to announce the successful passing of the U.S. Food and Drug Administration inspection. The issued certification paves the way for Grindeks cooperation with the U.S. partners, developing its business activities on the American market and allows Grindeks start exporting its manufactured Xylazine, Xylazine Hydrochloride and Droperidol to the U.S., as well as continue supplying Oxytocine and Detomidine to its American partners.
The inspection was performed by a U.S. Food and Drug Administration expert for 4 days and was already the 3rd inspection taken at the enterprise. The inspector visited Grindeks Active Pharmaceutical Ingredients (Oxytocine, Xylazine, Xylazine Hydrochloride, Droperidol and Detomidine) manufacturing facilities and audited the Quality system of Grindeks.
JSC Grindeks Chairman of the Board Juris Bundulis: “This successful achievement gives Grindeks new development opportunities and strengthens its position on the global pharmaceutical market, as the U.S. Food and Drug Administration approval is a convincing argument to gain the trust of every client. We are proud of our achievements in manufacturing and quality control and are looking forward to new export opportunities.”
The total JSC Grindeks Active Pharmaceutical Ingredients sales volume reached 12.7 million lats in 2012, with the U.S. exports volume of 0.5 million lats. Grindeks product portfolio includes 24 Active Pharmaceutical Ingredients. Grindeks manufactured Oxytocine represents a 30% world market share, and Droperidol – 92% world market share.