Sustainability Report 2010 Lek d.d.

15 Lek, a Sandoz Company – Company Identity Card 1.4 Overview of Lek’s commit- ment to external initiatives and principles 11 At Lek, the development and manufacture of medicinal products strictly comply with Pharmacopoeia requirements, WHO and OECD standards, requirements of the FDA and of the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP), and the Good Laboratory Practice recommendations. The development of medicinal products, APIs and manufacturing procedures is based on precautionary measures such as progressivity, inclusion of independent scientists, as well as open and transparent consideration of strengths and weaknesses. Lek implements a number of initiatives which form part of its commitment as a Novartis and Sandoz organization. These include the UN Universal Declaration of Human Rights, the ILO Declaration on Fundamental Principles and Rights at Work, the Rio Declaration on Environment and Develop- ment, the UN Convention against Corruption, the OECD Guidelines for Multinational Enterprises, the OECD Con- vention on Combating Bribery of Foreign Public Officials in International Business Transactions, and a voluntary com- mitment to reduce greenhouse gas emissions in accordance with the Kyoto Protocol. 1.5 Lek production sites and processes Ljubljana production site Located in the industrial zone of north-western part of Ljublja- na, Lek is the largest Slovenian and one of larger Sandoz units. On this location, manufacturing activities started in 1975 and expanded significantly in 1992 by the opening of a new tablet production plant which was further expanded in 2004. In 2008, the manufacturing was split into solid dosage forms production and steriles production. With about 80 APIs and more than 200 formulations manufac- tured and packaged, Lek Ljubljana is the leading Sandoz or- ganization in terms of product range size. In 2010, 127 million packages of different products were delivered from Ljubljana. Company headquarters, marketing and sales The Ljubljana site also features the company headquarters, administrative services, the HSE head office, the Patent Head Office, the Quality and Quality Management units, and the Sandoz Development Center Slovenia. Menge‰ production site At the Menge‰ site, the manufacture of active pharmaceuti- cal ingredients and solid dosage forms takes place. Other facilities include the Antiinfectives – Genetics development unit and the Quality unit. Furthermore, the site comprises one of the Sandoz’ main biopharmaceuticals development and production centers. At the Menge‰ site, spreading over two local communities, DomÏale and Menge‰, the manufacturing activity has been carried out for over 60 years (since 1946). APIs are manufactured by means of biological (fermentation) and chemical procedures (organic syntheses) followed by physical and chemical procedures for isolation and purification of active ingredients. In 2010, Tacrolimus and Omeprazole were the best selling products. Several new products were also launched, ensuring further growth of the site. Since 2000, the year when a new development laboratory for recombinant DNA technology was set up, the Menge‰ site has made considerable progress by implementing and developing this type of technology. The Biopharmaceuticals unit grew into a production facility through the inauguration of Slovenia’s first production plant for recombinant DNA technologies – PORT 1. It is complemented by the Biophar- maceuticals development center which employs 150 experts and joins all the major development functions in one place. Lendava production site At the Lendava site, the Antiinfectives unit and the Packag- ing center operate. In 1985, the API production started with Gentamycin, and in 1992, Potassium clavulanate followed. Based on stand- ard biotechnology which is the result of the company’s own Ljubljana production site Menge‰ production site 11 Disclosures GRI 4.12 and GRI 4.13