Sustainability Report 2013 Lek d.d.

13 Company Profile With our second Quality Control Center in Ljubljana we overcame spatial constraints which arose from the growing volume of operations. Quality The new Quality Control Center in Ljubljana Successful completion of construction of the second control center in a row for the implementation of quality control was one of Lek’s most important investments in 2013. This help- ed us overcome the spatial limitations of the first building constructed at the Ljubljana site in 2008, as our needs have grown rapidly due to production expansion. This investment confirmed the importance of quality control performed at all stages of drug manufacture. It first starts with the raw material tested. During manufacture, samples are then taken to perform testing and analysis of the finished pro- ducts. Before entering the market, drugs have to obtain final approval of conformity and all the packaging elements need to be checked before the packaging process is started. In the new building we perform the same activities as we have so far, but in improved conditions: control of raw mate- rials, regular testing of products and finished products, stabi- lity testing and the testing of samples for validation studies of technological processes. The new Control Center also hous- es a microbiological laboratory, changing rooms and storage for materials required for the microbiological laboratory. Sterile dosage forms The unit for sterile dosage forms manufactures parenteral drugs (injected directly in the body) filled into ampoules and vials. In 2013 we started regular production of lyophilized vials in the new Vials 2 facility and thereby increased annu- al production by 16.5 mio vials. The facility has state-of-the- -art equipment; in addition to a filling line with a capacity of 300 vials per minute, the new facility has three lyophi- lizers with an automated transport system. With this new acquisition the sterile dosage forms unit became one of the key Sandoz global production sites. Because of the addi- tional capacities and knowledge gained and built up over many years, the Ljubljana site acquired the role of center of excellence for vial and ampoule production within Novartis. Company headquarters The Ljubljana site also features the company headquarters with a number of specialist services – Legal Affairs, Regis- tration Competence Center SND/SEE, Supply, Quality, Health, Safety and Environment, and others. 1.3.3.2 Menge‰ site The Menge‰ site features the development and manufacture of active pharmaceutical ingredients, the production of sol- id dosage forms, the Antiinfectives - Genetics development department and the Quality unit. Production at this site has been carried out since 1946, and since 2000 it has wit- nessed fast development of biopharmaceuticals. The Menge‰ site is Sandoz’s key site for the manufacture and development of vertically-integrated active ingredients for pharmaceutical products which are finalized into finished dosage forms in the production network. APIs are manufactured by means of biological processes (fermentation), chemical processes (organic synthesis), physical-chemical processes for isolation and purification of active ingredients. More than 20 active ingredients are included in the production program. In 2013 the API production volume and utilization of production capacities again grew by more than 10%, primarily due to newly launched products. In 2013 we also became an important supplier of pharmaceutical ingredients for Novartis.