土耳其MN Pharmaceuticals
土耳其MN制药公司始建于1923年,现有员工1200名,是具有5家下属制药企业的跨国上市公司。主要生产抗生素类、心血管类、抗肿瘤类、消化系统类、神经系统类药物,形成了一个完善的药品质量管理和国际药物研发合作团队和体系。该公司生产的注射剂为土耳其首个通过美国FDA认证,产品销往欧、美、亚等23个地区和国家,2008年销售额达24.28亿美元。
MN Pharmaceuticals is one of the leading and oldest pharmaceutical companies in Turkey. The company was established in 1923 in a district of ?stanbul known as Üsküdar, ?hsaniye under the name of Mustafa Nevzat Laboratory.
Its founder Prof. Mustafa Nevzat P?sak played an important role in establishing contemporary pharmacy in Turkey, in changing the academic pharmacy program to one fashioned on Western methods, and in the development of Turkish Pharmaceutical Industry.
His "Laboratory" is one of the first manufacturers of injectable products in Turkey. With its 8 employees, the laboratory moved to another district, Divanyolu, and then to Nuruosmaniye in 1933.
In 1957 it moved to Mecidiyeköy and became a joint stock company. In 1984, in addition to the plant in Mecidiyeköy, the Yenibosna facilities were established. The plant in Mecidiyeköy, in turn, has moved to its present location at Yenibosna in 2003.
Currently, with its trained personnel of 1200 and modern facilities, MN Pharmaceuticals is one of the leading manufacturers of active pharmaceutical ingredients and finished dosage forms in Turkey.
In the four separate production units of the Active Pharmaceutical Ingredients Plant, penicillin group active substances, macrolide group active substances and etodolac, and other active substances are manufactured. In Production Plant I, penicillin group antibiotics like Sulbactam Sodium, Sultamicillin Tosylate and Sultamicillin Base are manufactured. In Production Plant II, Etodolac, Voriconazole and macrolide group antibiotics like Clarithromycin granules are manufactured. In Production Plant III and Plant IV productions of 1-500 kg capacities take place; in this Pilot and Small Scale Production Plants, active substances like Granisetron, Zoledronic Acid, Rocuronium Bromide, Aripiprazole, Monosodium Ibandronate Monohydrate and Imatinib Mesylate are manufactured.
In the four dedicated finished dosage forms production plants in Yenibosna, ?stanbul, all basic forms of pharmaceuticals, including injectables such as liquid and freeze-dried ampoules and vials, sterile powder vials and oral dosage forms such as hard gelatin capsules, tablets, film-coated tablets and dry powder suspensions are produced.
With its high-capacity injectable units and lyophilization facilities, MN Pharmaceuticals is Turkey's most experienced pharmaceutical company in parenteral drug manufacturing.
Penicillin-like and cephalosporin-like beta-lactam products are produced in two separate, dedicated plants.
In a separate and dedicated third plant, other groups of antibiotics, corticosteroids, cardiovascular agents, antiinflammatory agents, gastrointestinal agents and agents belonging to other therapeutic groups are manufactured.
The newly established and the fourth finished dosage form plant, Injectable Oncology Products Plant has been completed at the beginning of 2009. In this plant, dosage forms in liquid and freeze-dried vials are manufactured.
The products are manufactured according to "Current Good Manufacturing Practices (cGMP)" and "Current Good Laboratory Practices (cGLP)" and as a result of continuous training, education and modern technology, are offered to human health care both in Turkey and in various countries abroad.
In July 2004, MN Pharmaceuticals received EU-GMP certificate from Germany for the ampicillin sodium / sulbactam sodium for injection. This certificate has been renewed following the inspections in 2007 and 2009.
MN Pharmaceuticals signed strategic partnership agreements with several leading US generic companies for marketing and sales of its products and has submitted the first ANDA dossier to FDA in 2005. This is also a "first" for the Turkish Pharmaceutical Industry. By taking the initial step in exporting finished dosage forms to the US, MN Pharmaceuticals has paved the way for the other Turkish pharmaceutical companies to follow.
In November 2006, our API and finished dosage forms facilities have been inspected by FDA. As a result of FDA inspection, MN Pharmaceuticals has been the first Turkish Pharma Company which has been granted the FDA approval for the API and finished dosage forms.
The finished dosage forms facilities have been awarded the Environment Management System Certificate in the scope of ISO 14001 Standards by the British Management Systems Organization BSI in 2007. In May 2007, the first export of finished dosage forms was performed from Turkey to USA.
As a result of MHRA inspection conducted in May 2008, MN Pharmaceuticals received the Certificate of GMP Compliance of a Manufacturer from the British Ministry of Health. In July 2008, the second product has entered the US market.
In January 2009, following the certification investigation studies conducted by Turkish Standards Institute, MN Pharmaceuticals Active Pharmaceutical Ingredients Plant has been awarded the Environment Management System Certificate in the scope of TSE ISO 14001 Standards. The finished dosage forms facilities have been awarded the OHSAS 18001 Occupational Health and Safety Certificate which was presented by the British Management Systems Organization BSI. In January 2010, the third product has been launched in USA.
Prof. Mustafa Nevzat P?sak's professional aim of always accomplishing the best and his great respect for human welfare are still the basic principles of MN Pharmaceuticals.