Lek is a part of Sandoz, the generic division of Novartis, and a pioneer in the field of biosimilars and the second-largest generic pharmaceutical company in the world. Novartis is the leading provider of medicines in Slovenia, where further development is planned, as well.
Lek, a Sandoz company, has been helping to create the development flow in the global pharmaceutical industry for 70 years now and has been steadily growing over these years.
Our pharmaceutical generic organization operates in Slovenia, Europe and worldwide. It focuses on connecting with customers and evolving the future. With the help of our knowledge, quality and experience we became one of the key pillars of Sandoz.
We develop, produce and distribute effective, safe and high-quality medicines, ranging from standard generics through modern biosimilar medicines. The foundation of our success is our knowledge, innovation, courage and care for our patients' welfare.
We aim to build and preserve the reputation of a dynamic, ethical and trustworthy pharmaceutical company.
Besides being the leading development center of Sandoz, we are one of the key production sites for technologically demanding projects. Numerous innovative development projects are the result of our own knowledge and experience.
We operate within three development centers, namely:
- global development center for products and technologies;
- global development center for active pharmaceutical ingredients and medications,
- global development center for biosimilars.
It was the competence and knowledge of our associates that placed us among the most important Sandoz global production centers for active pharmaceutical ingredients and medications.
Despite the increasingly restrictive economic and financial situation, Novartis continues to invest in Slovenia. In total, Novartis has invested more than 1.7 billion Euros in development, modernization and expansion of production over the past 13 years.
The cornerstone of our success is our knowledge. We heavily invest in development, education and training of our associates. For decades, we have been actively involved in progressing Slovenian research and development space. We have a well-established cooperation with Slovenian Universities and Centers of Excellence and we are very successful in linking economy with science.
We live quality every step of the way. Quality is an essential part of our daily work and relationships with our associates, patients and customers. For several years, it has been recognized by regulatory authorities worldwide.
High quality standards are met in all work processes, drug development and manufacture, as well as market supply with our highly qualified and experienced experts playing the key role.
We are proud to be the leading Sandoz company and introducing new products to the global markets.
Social act socially responsible. We believe that business success and social responsibility go hand in hand.
- We strive to increase access to healthcare services, medicines and raise awareness on health issues.
- We are a responsible and ethical employer and active community member.
- We adopt a preventive approach, striving to make efficient use of natural resources and minimizing our environmental impact.
- We operate in accordance with the highest standards of ethical business conduct.
We share a common vision
Patients are the center of our operations.
We pursue Sandoz’ common vision: daily improving access to high-quality medicines to help secure healthcare for people around the world. We are committed to making health available to everybody.
As a Sandoz company, we would like to lead the generic pharmaceuticals industry and continuously set new higher quality standards. Our innovation agenda includes new drug delivery systems as well as very highly complex biosimilars.
Decades of experience and professional know-how are incorporated in the medications that we are manufacturing. Our investments in development are extensive and subject to strict international quality standards.
Our culture is based on strong values. They help us implement our mission and vision, choose associates, develop talents and award achievements.
We are guided and connected by:
Our solutions reflect our innovation. To achieve excellence we put quality into everything we do. High-performing inclusive and diverse teams are connected and working in collaboration.
Performance helps us make decisions and act on them. Adopting a courageous mindset drives us to speak up, give and receive feedback. By advocating and applying integrity every day, we are committed to high ethical standards.
Our sites across Slovenia
More than 3400 employees are helping to create our success at four sites across Slovenia; in Ljubljana, Lendava, Mengeš, and Prevalje. During the past four years we employed more than 1100 new associates.
The headquarters of the company Lek d. d. is in Ljubljana, where Development, Quality Control, production, Sales & Marketing, Regulatory Competence Center Commonwealth of Independent States/South-eastern Europe (CIS/SEE) and the majority of support functions are in operation.
Sandoz Development Centre Slovenia
A quarter of Sandoz most important development projects are under way at the development center in Ljubljana. We manage the technologically demanding development projects. In 2015, we developed and filed dossiers for 21 new products for the most demanding global markets, in total for more than 100 new products over the last four years. The largest number of newly developed products was launched to markets in Europe, Canada, Australia, USA and Japan. At the end of 2015, more than 240 development projects were in the pipeline at the Sandoz Development Center Slovenia. Their complexity increases in line with the company’s strategy.
Quality Control Center
Before drugs enter the market, they have to take a long and complex journey. Quality control definitely plays an important role in this process and is incorporated at all the stages of drug manufacture. It starts with raw materials being tested at the Control Center and then released into production before the start of the manufacturing process. During the manufacture, samples are taken to perform testing and analysis of finished products. Before entering the market, drugs have to obtain final approval of conformity. Consequently, all the packaging elements need to be checked before the packaging process begins. Only after the conformity of the product has been tested, the product can be released to the market.
Ljubljana site produces solids and steriles.
The Solid dosage forms unit has a broad range of products – we have around 100 different types of molecules in more than 500 bulk products, which are packed into over 2,400 finished products for a wide range of markets around the globe, including the most demanding markets such as the US and Japan.
The production of solid dosage forms involves making granulates, tablets, capsules, film-coated tablets, sugar coated tablets, pellets and micropellets, which are then packed into blisters, sachets or containers (plastic or glass bottles).
At the Sterile dosage forms production plant, sterile dosage forms are produced and filled into ampoules and vials.. We also manufacture solutions, nasal sprays and syrups. We are the Novartis Excellence Center for ampules and Sandoz’ Excellence Center for lyophilized powder contained in vials.
More than 45 active ingredients are used to produce over 70 different products, which are packaged into over 530 finished products for a wide range of markets around the globe.
The Mengeš site features three key activities, as follows:
- Development and Production of Active Pharmaceutical Ingredients (using chemical organic synthesis and fermentation),
- Development and Production of Biosimilars (using recombinant technology), and
- Development of Anti-infectives.
Development and Production of Active Pharmaceutical Ingredients
80% of all Sandoz non-anti-infectives are produced at the Production of Active Pharmaceutical Ingredients site in Mengeš. A minor part of the production is still based on plant extracts; finished products (probiotics) are also manufactured.
In 2016, the Mengeš site will reach a new milestone by developing technologically demanding pharmaceutical ingredients for one of the Novartis most important original medicinal products. By introducing innovative pharmaceutical industry to Slovenia we have made a remarkable achievement. It is our knowledge, lengthy experience and quality production of active pharmaceutical ingredients that contributed to the Novartis decision to choose the Mengeš site for this investment.
Sandoz is the pioneer and global leader in biosimilars. It has an industry leading pipeline including monoclonal antibodies, the largest and fastest-growing part of the global biologics market. Sandoz now has a number of biosimilars molecules in various stages of development and has announced its intent to make ten regulatory submissions between 2015 and 2017.
Biopharmaceuticals Mengeš is the only center for recombinant biotechnology in Slovenia and is one of most important Sandoz sites for development and production of biosimilars. One of the three Sandoz biosimilars (epoetin alfa) is produced at this site. The European Medicines Agency approved all three biosimilars, which are also available to patients in Slovenia.
Novartis has invested more than 64 million Euros in development as well as production at Biopharmaceuticals Mengeš.
Development of Anti-infectives
Mengeš site has two development departments – Genetics and Microbiology and fermentation. They focus on antimicrobial medicinal products manufactured using biotechnological methods. By improving the procedures for producing active pharmaceutical ingredients, the experts in this department are significantly contributing to the development of affordable generic medicinal products.
Sandoz investments and modernization of production capabilities sum up to nearly 200 million Euros in the past decade reflect the advantages of the Mengeš site.
Anti-infectives Production Lendava
All active pharmaceutical ingredients are manufactured using classical biotechnological methods developed and based on our own knowledge. One of the most important products manufactured at the Lendava site is the potassium clavulanate. It is the key ingredient of our leading broad-spectrum antibiotic.
Packaging center Lendava
Established in 2009, the Packaging center Lendava has been one of the two Sandoz strategic packaging centers. The packaging center supplies European and global markets with medicinal products from Sandoz production sites around the world while expanding its production capacities.
Over the past decade, Sandoz invested more than 110 million Euros into the development and modernization of capabilities at the Lendava site.
At the Prevalje site we manufacture a broad-spectrum antibiotic with amoxicillin-clavulanic acid, one of Sandoz leading products. In three decades, we produced 5 billion of tablets.
The Prevalje site has been operating for over 35 years and during this period Lek has been the main employer and development catalyst in the Carinthia region, from where the majority of our employees come from.
Over the past ten years, Sandoz invested nearly 22 million Euros into development and modernization of production capabilities at the Prevalje site.