Sustainability Report 2010 Lek d.d.

Lek, a Sandoz Company – Company Identity Card 16 know-how, the manufacture of Potassium clavulanate by using standard fermentation is currently performed along with the production of Gentamycin sulphate. Lendava is the leading location for the manufacturing of Potassium clavu- lanate in the Sandoz Group, and its demand continues to increase. Gentamycin is a wide-spectrum aminoglycoside antibiotic for hospital use in severe bacterial infections. Lek is an important manufacturer of Gentamycin outside China and South Korea. Since 2009, a packaging center has operated at the Lendava site. The center supplies EU markets with finished products from Sandoz plants all over the world. Prevalje production site At the Prevalje site, a single-purpose production plant for penicillin products operates. In 1978, the present plant for pharmaceutical and dental pro- duction became an integral part of Lek. A decade later, the Prevalje plant started the manufacture of a broad-spectrum antibiotic from the group of beta-lactame antibiotics, i.e. a combination of potassium clavulanate and amoxicillin with a broad spectrum of antimicrobial action. Potassium clavu- lanate is produced at the Lendava site, whereas amoxicil- lin is obtained from a Sandoz location outside Slovenia. The broad-spectrum antiobitic is one of Lek’s and Sandoz’ major products, its sales having doubled in the 2003-2009 period. It is manufactured in the form of tablets or powders for peroral suspensions. The process of packaging these into finished products and in the form of mixtures and granules, intermedi- ate products for further processing, is also carried at this site. Lendava production site Prevalje production site Glossary of key terms GRI (Global Reporting Initiative) GRI Guidelines represent one of the world’s most prevalent standards for corporate responsibility and sustainable deve- lopment reporting. They require planning and reporting ac- cording to measurable indicators of economical, social and environmental impact of an organization. Depending on the scope of disclosures and measurable indicators, reports are classified into three application levels (C, B and A). A “plus” (e.g. C+) signifies that the report was reviewed by an inde- pendent third party. GRI Guidelines provide a high degree of comparability, transparency and consistency of non-financial corporate reports, increasing stakeholder trust in corporate responsibility and sustainable development reports. EMAS (Eco-Management and Audit Scheme) The EMAS Scheme was designed for enterprises to impro- ve their environmental performance and to inform the public of the environmental impacts of their operations. It is ba- sed on the ISO 14001 standard, upgraded with additional requirements for a more open communication, credibility and periodic publishing of verified environmental informa- tion. Environmental statement is the basic method of publicly communicating the results of continuous improvement of the organization’s environmental performance, and an opportu- nity to enhance the company’s reputation with customers, suppliers, contractors, community and employees. RCI (Responsible Care Initiative), a global, voluntary initi- ative developed autonomously by the chemical industry Launched in 1981 in Canada, the initiative was adopted globally by the chemical industry represented by the ICCA (International Council of Chemical Associations). Within the framework of the initiative, the chemical industry encourages responsible treatment of employees and the environment in its broadest sense. It focuses on the implementation of Good Practices, usually through management systems, particularly in the fields of occupational health and safety, environmental protection, and cautious and safe handling of chemical indu- stry products. The initiative aims to provide constant and mea- surable improvement of operations in the aforementioned fields, which is measured by means of 16 indicators. Three indicators reflect occupational safety and health achieve- ments, while the remaining ones are concerned with envi- ronmental management, including energy efficiency. Generics Generics are successors to pharmaceutical products whose patent protection has expired. Generic medications are just as effective, safe and quality as the original branded equiva- lents but they are sold at more affordable prices. The Bioequi- valence Study has to prove that generic medicinal products are identical to the previously patented original. The clinical comparative study guarantees that generic medicines contain the identical active ingredient, dosage, effect and patient to- lerance. In addition, the manufacturer has to prove that each step in the manufacturing process complies with the highest quality standards. This begins with API manufacture, continu- es with the control of the entire manufacturing process, and ends with the finished product analysis. Approval for the sales of a generic drug is granted only if all the criteria have been met. Although no basic research is needed, generic products necessitate many years of extensive research work.