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Leading pharmaceutical company in C&E Europe receives FDA approval

The leading pharmaceutical company in central and eastern Europe Pliva has announced that the US Food and Drug Administration Inspection Agency has granted approval to its manufacturing facilities in Zagreb.

In a statement, the company said that the FDA completed the Pre-Approval Inspection and Good Manufacturing Practice Inspection covering the quality control, laboratory and production systems of the manufacturing site in Zagreb at the end of August. The facility includes the new Oral Dosage Form facility.

This followed the Medicine Control Agency Inspection and approval for solid dosage forms and sterile injection products at the manufacturing facilities in Zagreb in July 2002. The approval allows Pliva to register products in the US and the UK and will help the approval process in other Western European countries.

(NewsBase 11.xi.02)

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