February 21, 2007,Istanbul. Following completion of its inspections at MN Pharmaceuticals, one of the leading companies in the Turkish pharmaceutical field, Food and Drug Administration (FDA) has concluded that the production standards meet the USA standards. FDA, which gives the approval for new drugs in the US, is accepted as the most important official organization to specify the standards in this field worldwide. FDA inspections were started after MN Pharmaceuticals’ license applications in the US. MN Pharmaceuticals, with its 27 files in registration phase at FDA, will be the first Turkish company to export drugs to the United States after receiving the required licenses. MN authorities emphasized that they have aimed for competitive business markets for the US and that they are planning to export 300 million dollars worth of pharmaceuticals in 2012.
Following registration applications, FDA inspectors came to Turkey and inspected MN production facilities both for general quality systems and for all processes related to production and documentation. The FDA approval given to production plants will enable MN products to be registered in the US. MN Pharmaceuticals has signed strategic agreements with pharmaceutical companies in the US for sales, distribution and marketing. These agreements will provide great benefits to MN Pharmaceuticals for marketing its products in the US.
Chairman of MN Pharmaceuticals, emphasized that the FDA approval is an important step not only for MN Pharmaceuticals but for all Turkish Pharmaceutical sector and went on as follows:
"MN Pharmaceuticals, which has been a leader in Turkish Pharmaceutical field, is accomplishing its mission in opening-up to foreign markets. With FDA approval, we will have the opportunity to present our products to the US market, which is the greatest pharmaceutical market. We believe that our pharmaceutical companies should have a global vision and should open-up to foreign markets. We believe that the Turkish drug sector has the technical capacity and qualified man-power to accomplish this. The success of MN Pharmaceuticals is a proof of what our sector can accomplish on a global basis. It is our belief that many pharmaceutical companies will follow us in the path we have just opened."
Levent Selamoglu, CEO of MN Pharmaceuticals, reminded that they have put great importance on always to perform at the highest standards and stated that they are happy and proud to receive the FDA approval. He went on as follows:
"Successful completion of the FDA inspection will provide us an important advantage in the US market. Currently, we have 27 submitted files for approval in USA. We have serious goals in the US market. We aim to export 300 million dollars worth of products to the USA in 2012."