MCA inspection confirms Lek's manufacture of Amoksiklav meets all requirements for the British market

26. 6. 2001

Ljubljana, June 26th – The international pharmaceutical company Lek d.d. (Lek) received approval of its Amoksiklav manufacturing facilities in Prevalje from the British Medical Control Agency. The MCA inspection, which is similar to United States Food and Drug Administration (FDA) procedures, is considered one of the toughest, if not the toughest, in the production of drugs in Europe.

The MCA authorization once again recognizes Lek’s first-class expertise as well as its high quality production, which in the pharmaceutical industry are the key to manufacturing safe, effective and quality medicines.

Amoksiklav is a broad spectrum antibiotic. It is prescribed for treatment of a wide array of infections; ranging from upper and lower respiratory systems, urinary tract, reproductive organs, skin and soft tissues, bones and connective tissues, gum tissue, to animal bites and so on.

We at Lek are particularly proud of the fact that clavulanic acid, which is added to the antibiotic, was developed through our own know how by using the latest technologies. This proves once again that Lek is not just another generic drug manufacturing company.

Amoksiklav was launched in Slovenia in 1990. Registrations, approvals and marketing abroad soon followed.

Today, Amoksiklav is renowned as an effective, safe and up to date antibiotic. Under different trade names, it is approved and marketed in over 40 different countries and manufactured, under Lek license, by numerous partners.

In 2000 Amoksiklav, Lek’s flagship product, was again Lek’s top selling finished pharmaceutical product. It accounted for 20.9% share of Lek’s total sales and exceeded sales of the previous year by SIT 3 million. Amoksiklav is not only our leading product but also a product with one of the fastest growth rates. Its sales grew by 34.8% from the previous year.

The next steps in Lek’s entry to the British antibiotic market are: approval of Amoksiklav, and finalizing a marketing agreement with our British partner. These negotiations are almost complete. Lek plans to collaborate in the British market with one of the key members of the British pharmaceutical industry.

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This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected

For additional information, please contact Katarina Klemenc, Head of the Public Relations Department, Lek d.d., to the phone number: (01) 580 22 43