Lek is enhancing its production network with a new plant in Mengeš, Slovenia, for the production of hypolipemic active ingredients

“The new plant for the manufacture of hypolipemic active ingredients in Mengeš is an important link in the Sandoz production chain for the global manufacture of active ingredients. With this plant, Lek is clearly implementing the strategy of the Mengeš site, an important production centre in the Sandoz network for selected active ingredients destined for global markets,” said Igor Boševski, MSc, the Mengeš site head at the opening of the plant. The new Lek facility was constructed in a little less than a year and a half, which is a short period for operations of this size and complexity. This is an investment of over three billion Slovenian tolars, and the plant and its technology are entirely the product of Lek’s domestic know-how. In the new plant, about 20 employees will be on hand to ensure an undisturbed work process.

Initial phases in the production of hypolipemic active ingredients take place in Italy and at Lek’s Lendava plant, while in Mengeš the finished form of the active ingredients is produced for further pharmaceutical use. At the new plant in Mengeš, Lek will perform operations for purifying the input material and controlling the crystal forms, which will involve modern techniques for separating impurities from the main component of the active ingredient. This procedure yields a high degree of purity of the active ingredient, leading to a better quality and greater stability of the finished product. The active ingredients obtained in this manner will be added to the finished pharmaceutical product (tablets) in Lek’s Ljubljana plant and at other sites within Sandoz. The major portion of the active ingredient output from Mengeš will be used in this manner, i.e. according to the principle of vertical integration, which is also one of the strategic pillars of Sandoz.

In the production of active ingredients, the construction and operation of such facilities must be in compliance with standards of good manufacturing practice, which are legislated for all manufacturers of active ingredients in the EU and the USA. Since the plant produces the finished active ingredient, which is further processed into tablets, the standard of cleanliness at the plant is very high. All of the areas are designed as rooms with enhanced cleanliness, including so-called clean rooms; the equipment is made of stainless steel and electrical equipment is designed to be explosion-proof. Intermediates are transported within the plant and between processing steps within an enclosed system, so that they do not come into contact with the external atmosphere, thereby protecting the active ingredient from environmental contamination, as well as ensuring an appropriate degree of occupational safety for employees and preserving a clean environment. The plant is automated, which contributes to greater safety and reliability in the process, although the critical points are still controlled and operated by personnel. At the plant there is high emphasis on safety and process control systems to prevent errors and reliably maintain chemical processes within safe limits.

The new manufacturing plant in Mengeš is constructed in compliance with environmental protection requirements. The floor of the plant is designed as a containment system, which catches any spillages and thus prevents them from contaminating the environment. The major portion of organic solvents is reused within an enclosed cycle, while a small portion is disposed of through incineration, mostly at incineration plants abroad. Emissions into the atmosphere are controlled using a separate apparatus which makes sure that no substances with unpleasant odours are emitted into the air and that all emissions are within the limits defined by EU legislation. Limits applicable to such emissions are the result of long-term international scientific research, and reliably provide an appropriate level of protection for the environment. Environmental protection standards are set by the European legislation and its provisions are applicable in their entirety also in Slovenia.

The new plant in Mengeš was officially opened by the mayor of Mengeš, Tomaž Štebe MSc, the Director of Lek’s API Production in Mengeš, Igor Boševski MSc, and the plant head, Matjaž Tržan MSc. The mayor of Mengeš, Tomaž Štebe, MSc, said upon this occasion that the economic development and growth of companies are also the assurance of the development of local environments in which Lek operates. Lek, a Sandoz company, has proven its business efficiency over the years by running and opening of new plants in Mengeš, and also by respecting all of the ecological and social aspects of business operations. With such an approach, Lek is a productive and important partner of the local community and its development. He also added: “The Mengeš Municipality has enjoyed excellent cooperation with Lek d.d. and we are pleased with the company’s major investments in new technologies and the modernization of existing ones. We are especially satisfied with the particular attention and importance that Sandoz has placed on sustainability, especially with regard to environmental and safety aspects in particular. To Lek Pharmaceuticals d.d. and Sandoz, I wish that this will be a safe and successful investment over the long term.”

***

Lek, a Sandoz company, is one of the pillars of leading world generics company Sandoz. It operates as a global development center for products and technologies, as a global manufacturing center for active pharmaceutical ingredients and medicines, as a competence center for the development of vertically integrated products, as a Sandoz competence center in the field of development and manufacturing of biopharmaceutical products and as a supply center for the markets of CEE, SEE and CIS, sales Slovenia and sales services for Sandoz’s global markets. Lek d.d. employs about 3,037 people in various regions and achieved total sales of USD 746.5 million in 2004. For further information please consult http://www.lek.si

Sandoz, a Division of the Novartis group, is a world leader in generic pharmaceuticals. Sandoz develops and markets a wide variety of active ingredients and finished products, including biopharmaceuticals and anti-infectives. Since June 2005 Hexal AG, Germany, and since July 2005, EonLabs Inc. U.S., are part of Sandoz. In 2004, Sandoz employed around 13,400 people worldwide and posted sales of USD 3.0 billion. The combined businesses had pro forma 2004 sales of USD 5.1 billion and more than 20,000 employees.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group’s businesses achieved net sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.