Sanovel İlaç Receives FDA Approval for United States Market

Sanovel İlaç, through its approval from the U.S. Food and Drug Administration (FDA), which is regarded as the world's leading institution in establishing standards for pharmaceutical manufacturing, has certified that its production processes comply with American standards. The GMP inspection conducted at Sanovel İlaç's Silivri production facility covers the quality systems of the entire facility, including sterile manufacturing areas. Sanovel İlaç Board Chair Ahmet Toksöz, noting the importance of the FDA approval not only for Sanovel İlaç but also for Turkey's pharmaceutical industry, added: "This success is a source of pride for both our company and our country. In line with our global vision, we continue our international operations. With this approval, we will achieve the strength to establish a presence in the American market." Sanovel İlaç, which has continued international operations since 2005 and exports to countries including Georgia, Azerbaijan, Kazakhstan, Kyrgyzstan, Uzbekistan, Russia, Iraq, Albania, Turkmenistan, and Spain, has achieved the distinction of being the first and only Turkish pharmaceutical company to have received FDA approval with no major or critical findings, an accomplishment that is extremely difficult for other companies worldwide. Following successful passage of the FDA inspection, Sanovel İlaç continues its export efforts to the United States, the world's largest pharmaceutical market, at full pace. As a result of these efforts, the company is on the verge of receiving approval for its first licensing application filed last year. Sanovel İlaç, which has achieved numerous accomplishments that are a source of pride for Turkey's pharmaceutical industry, ranks among companies that have won awards and filed the most patents in the pharmaceutical sector in Turkey for many years, thanks to its emphasis on R&D. The company previously became the first Turkish firm to receive patents from the U.S. Patent Office for four drug formulations it had developed, and the drug formulations it developed with entirely domestic capital obtained patent protection rights from the United States through 2033.