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

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