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<p align="center"><b>PLIVA Facilities Pass Food and Drug Administration (FDA) |
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Inspection</b></p> |
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<p>Zagreb, 27th October 1999</p> |
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<p>PLIVAs new Azithromycin facility was found to be in compliance with good manufacturing |
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practice according to the Food and Drug Administration (FDA) inspection carried |
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out in mid-October of 1999. </p> |
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<p>Azithromycin is PLIVAs leading product and is exclusively supplied to Pfizer |
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according to a licensing agreement. This was the first inspection by the FDA |
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of the new Azithromycin facility in Savski Marof, which was completed at the |
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end of 1998. Upon receipt of FDA approval of the changes to the Azithromycin |
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NDA (New drug application) submitted by Pfizer, PLIVA will be in a position |
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to commence shipments of Azithromycin produced in the new facility to the United |
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States. The new facility has the capacity to meet all PLIVA and Pfizers forecasted |
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demands for Azithromycin.</p> |
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<p>The FDA also carried out inspections of other PLIVA facilities involved in |
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the production of a range of active pharmaceutical ingredients for sale on the |
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US market. Authorisation to begin or resume usage of active pharmaceutical ingredients |
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produced in the facilities that were subject to this routine inspection should |
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be given to customers by the FDA shortly.</p> |