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ROMANIAN TRADITIONAL BRANDS: Antibiotice S.A. Iasi

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Pharmaceutical company Antibiotice Iasi (country north-east) is Romania's leading producer of generic drugs and the country's only manufacturer of active substances obtained by biosynthesis (brand name Nistatina, based on the antibiotic Nystatin).

The producer's 137-strong drug portfolio covers a wide range of therapeutic areas, with the product development strategy focusing on cardiovascular, anti-infectious and central nervous system medication. On the domestic market Antibiotice is the major producer of anti-infectious drugs, Agerpres informs.

Antibiotice relies on all major forms of certification to prove the quality of its products: Good Manufacturing Practice for all its 8 production lines; Certificate of Suitability to the European Pharmacopoeia (CoS); and Food and Drug Administration (FDA) certified producer of Nistatina and injectable products.

Romania's first pharmaceutical company and the first in South-Eastern Europe to produce penicillin (a group of antibiotics derived from Penicillium fungi discovered by Alexander Fleming) on a large scale was set up in December 1955, under the name of the Chemical Factory No. 2, Iasi. Four years later, the streptomycin production section was commissioned and the production of ointments, creams and suppositories started too.

Beginning with 1960, the company develops its technological flows for the manufacturing of active substances (erythromycin, oxytetracycline, tetracycline, griseofulvine, sinerdol, lysine). In that time the plant is the only manufacturer of sterile parenteral (injectable) products in Romania. The approval, in 1977, of the company's streptomycin production flow by the U.S. Food and Drug Administration (FDA) opens the international market to Antibiotice Iasi.

In the '80s, Antibiotice was already exporting 50 percent of its production. The active substances produced here were thus incorporated in a broad range of medicines from the in-country and global production. As many as 44 patents for pharmaceutical inventions were registered in the same period and about 600 technological innovations were implemented in the production process.

After 1990, following sweeping macroeconomic changes, the company redirects its production of medicines, with finished products gaining a leading position in its portfolio; the active substances produced in this period are used to develop new formulations. Within short, over 30 pharmaceutical products hit production, placing the Iasi-based company among Romania's top producers of anti-infectious drugs.

Between 1993 and 1997, the plant management invests more than eight million euros in re-engineering and the acquisition of modern and competitive equipment. Antibiotice climbs to the top five global producers of penicillin and penicillin derivatives.

Concerned with the quality of its products, the company has been implementing since 1997 a performing quality assurance system which involves the strict control of the manufacturing processes. In 1999 Antibiotice became the first manufacturer in Romania to hold the Good Manufacturing Practice (GMP) certification for its flow of injection powders. With the upward financial trend the company checks another notable performance: getting listed on the Bucharest Stock Exchange.

At its 50th anniversary in December 2005, Antibiotice launched a new logo and a new slogan reflecting the massive organizational, technological and cultural changes that put their mark on the company. Also in 2005, its pre-tax profit reached 5.2 million euros, by 173 percent higher than the figure posted in 2000.

In 2006, the Quality Management System of Antibiotice Iasi gets Lloyd's Register Quality Assurance ISO 9001:2000 certification for pharmaceuticals manufacturing.

The company also develops its own Drug Evaluation Center, on an investment of over one million euros. The decision for the investment was determined by the need to conduct in-company phase I clinical trials and especially bioequivalence studies.

In February 2007 Antibiotice obtains the recognition of the implementation of the Integrated Management System (quality, environment , work health and safety).

In June 2010, the company performs the first delivery of finished products (injectable drugs) to the U.S. market, and in 2011 its injectable sterile powder penicillins obtain the FDA authorization, allowing the expansion of exports of such products to the U.S.

Also in 2011, Antibiotice releases its first central nervous system medicine products. In 2012, the company enters the market of oncology drugs and becomes the first European company on the World Health Organization's pre-qualification list for the range of anti-tuberculosis drugs.

In 2013 Antibiotice climbs to world No. 1 in the production of active substance Nystatin, performs its first shipment of Nafcillin to the U.S. market and opens an international representation in Chisinau, Republic of Moldova.

Over time, the Iasi-based Antibiotice company has been honored with a number of distinctions and awards that include: the Diploma of Excellence; laureate in three consecutive years of the 'Top Companies' ranking of the Chamber of Commerce and Industry; Rommedica Diploma of Excellence (2001); the honorary Diploma 'Most dynamic medicines exporting company' ANEIR (2009); ANEIR Trophy 'Most dynamic manufacturer and exporter of medicines in Romania' (2012); the Order of Industrial and Commercial Merit in the rank of Commander (2013).



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