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<p><b>Our Profile</b></p> |
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<p>The Fine Chemicals business has traditionally been oriented towards exports, |
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approximately 90% of its production is exported. 10% is sold intra-group on |
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an arm's length basis. </p> |
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<td width="170"><font color="#CC6633"><b>Croatia</b></font></td> |
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<td width="50"><img src="fc/graph_12.gif" width="45" height="24"></td> |
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<td width="170"><font color="#CC6633"><b>Captive</b></font></td> |
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<td width="50"><img src="fc/graph_11.gif" width="45" height="24"></td> |
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<td width="170"><font color="#CC6633"><b>Export </b></font></td> |
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<p><b>Exports by region:</b> <br> |
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64% of Fine Chemicals production is exported to the United States, 35% to Western |
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Europe and 1% to others.</p> |
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<td width="30"> </td> |
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<td width="175"><img src="fc/graph_21.gif" width="160" height="24"></td> |
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<td width="45"><font color="#CC6633"><b>USA</b></font></td> |
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<td width="175"><img src="fc/graph_22.gif" width="102" height="24"></td> |
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<td width="45"><font color="#CC6633"><b>EU</b></font></td> |
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<td width="175"><img src="fc/graph_23.gif" width="36" height="24"></td> |
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<td width="45"><font color="#CC6633"><b>Others </b></font></td> |
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<p> <b>Quality system</b> </p> |
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<p>Our quality system is aimed at:<br></p> |
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<td width="150"><img src="fc/QualitySystem.jpg" width="150" height="144"> </td> |
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<td valign="top" width="35"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>defining what to do and specifying how to do it</td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>justifying these activities (optimizing/validating)</td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="11"></td> |
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<td>training</td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>following SOPs </td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>documenting performance </td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>inspecting implementation </td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>tracing failures/corrective actions </td> |
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<p> <b>Regulatory compliance</b> </p> |
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<p>We have a spotless regulatory compliance track record. <br> |
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</p> |
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<td valign="top" width="35"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td> DMFs have been submitted for 11 APIs in USA, Canada, Europe, New |
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Zealand, Australia & South Africa</td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>Since 1965 28 US DMFs have been submitted to the FDA </td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>Since 1965 FDA inspections have been continuously performed </td> |
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<td valign="top"><img src="fc/point_2.gif" width="35" height="12"></td> |
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<td>In 1999 a 20th FDA inspection was successfully performed on five |
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products</td> |
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<p><b>Environmental protection</b><br> |
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</p> |
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<td width="157" valign="top"><img src="fc/slap02.jpg" width="150" height="272"></td> |
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<p>Environmental protection is a key strategic priority for us. Ecological |
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programs are managed in parallel with each of our new projects. </p> |
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<p>PLIVA - Fine Chemicals has developed a programme designed to ensure that |
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health and safety procedures and environmental protection safeguards comply |
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with relevant enviromental laws and regulations and, in certain areas, |
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with the requirements of various foreign regulatory bodies to which PLIVA's |
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plants are subject. </p> |
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<p>PLIVA's programme envisages rising production standards in the Republic |
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of Croatia as the country orients itself increasingly towards EU standards |
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in this area. </p> |
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