Lek d. d. Successfully Completes Third FDA Inspection in Two Years
Ljubljana – The US Food and Drug Administration has completed a comprehensive inspection of several of the Company’s facilities during the period of June 17 to July 4, 2002. The inspected facilities all related to the production of one of Lek’s strategic products, the antibiotic Amoksiklav (amoxicillin/potassium clavulanate).
The inspection of the Lek facilities were part of the normal review process of Lek’s regulatory dossiers for a number of different presentations of Amoksiklav with the US authorities. Four Lek facilities were inspected Lendava, the production site of potassium clavulanate, Prevalje, the penicillin dosage plant, the product development site at Menges and the dosage development and analytical laboratories located on the Ljubljana campus. In addition, laboratories of one of Lek’s subcontractors in Ljubljana also were included in the inspection.
Several items are noteworthy. The investigators used the most recently published standards for the production of pharmaceutical active ingredients – ICH Q7A. This was the first inspection of the Prevalje facility. Most important, however, is the fact that at the end of the inspection, no adverse observations were presented to the Company’s Management by the investigators. The Company’s management is pleased with the result of the inspection that continues the trend set with the two previous successful inspections since the beginning of 2001.
The favorable outcome of this comprehensive inspection reaffirms Lek’s strategic focus on the US market and is expected to reinforce our position in the extremely demanding market to ensure its full future growth potential with our lead product Amoksiklav.
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.
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For additional information, please contact: Miša Komar Žiberna, Lek’s Corporate Communications Telephone: + 386 1 580 22 43