13 / 07 / 2015
On June 3rd 2015, following a compliance inspection by the Spanish authorities, the Tereos Starch & Sweeteners plant in Zaragoza, Spain, obtained the GMP (Good Manufacturing Practice) certificate for the manufacture and release of Meridex® Pyrogen Free Glucose Monohydrate as an Active Pharmaceutical Ingredient. This product is fully compliant with the principles of GMP for Active Pharmaceutical Ingredients. Glucose Monohydrate produced in Zaragoza fulfils all of the European and US Pharmacopoeias parameters, and also meets the requirements of various applications such as parenteral nutrition, dialysis and injection solutions.
The production unit was specifically designed for Glucose monohydrate in September 2011 and uses the most modern technologies known to the field. The first products were supplied to the food sector in January 2013 and then as excipients to the pharmaceutical market in September 2014.
The GMP certificate number is ES/094/15. It was delivered on June 3rd 2015 by the AEMPS (Agencia Espanola de Medicamentos y Productos Sanitarios). It is available on the EudraGMDP database.