The holder of the registration certificate for the drug "TRILEXA®" (Registration certificate number - LP-No.(007693)-(RG-RU)) is Tyutor S.A.S.I.F.I.A., Argentina.
Tyutor S.A.S.I.F.I.A. Company, Argentina (
www.tuteur.com.ar) is a manufacturing company with more than 50 years of experience in the pharmaceutical industry and the promotion of high-tech drugs in such areas as oncology, hematology, nephrology, pulmonology, diseases of the central nervous system, autoimmune and orphan diseases, exports pharmaceutical products to all over the world since the 80s.
Tyutor has two own production facilities in Argentina with a total area of 7,500 m2 with an installed production capacity of more than 105 million metered units per year, which allows it to meet national and international demand for the company's medicines.
In addition to its own pharmaceutical production and export of pharmaceutical products to Europe, Latin America and the CIS/EAEU, Tyutor has also been exporting raw materials for the pharmaceutical industry to European countries - France, Germany and Italy since 1980.
Tyutor focuses on comprehensive quality management: adheres to strict rules of good manufacturing practice, uses strict standard operating procedures for incoming quality control of pharmaceutical substances and excipients. The company's production sites comply with the requirements of good manufacturing Practice (GMP) and have a valid GMP certificate issued by the National Institute of Medicines, the expert authority for Medicines, Food and Medical Technologies of Argentina (A.N.M.A.T. – national regulatory structure, equivalent to the FDA, USA). Compliance with the requirements of good manufacturing practice (GMP) in accordance with the current regulations of the Argentine Republic, as part of the application of the recommendations of the World Health Assembly (WHA) and the International Conference on Harmonization (ICH) is checked regularly as part of inspections for the annual renewal of the GMP certificate.
Since 2008, the Office of Medicines, Food and Medical Technologies of Argentina (A.N.M.A.T.) has been an active member of the international PIC/S (Pharmaceutical Inspection Co-operationScheme - Pharmaceutical Inspection Cooperation Scheme) scheme, which confirms the recognition by the global industry community of the level of pharmaceutical production in the country and its proper inspection and guarantees a consistently high the quality of the company's pharmaceutical products.
Tyutor's portfolio includes more than 120 products, 23 of which are registered and have been supplied to the pharmaceutical market of the Russian Federation for about 30 years. During this time, no complaints have been received regarding the quality of pharmaceutical products from this manufacturer.