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Submission: On March 16 via manual from AU — Scanned from DE
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<h1><br><span id="ContentPlaceHolder1_ContentPageHeading"></span></h1>
<p></p>
<h1>Fine Chemicals Corporation</h1>
<p>The business of Fine Chemicals Corporation was established in Cape Town, South Africa in 1962. Initially, products including Codeine Phosphate, Morphine Sulphate and Paracetamol were targeted at the local South African market and in the
mid 1980's a range of off patent generic API's were developed in-house. These were largely destined for the US market.</p>
<p><a href="//FileAssets/ContentCast/25/FCC_Poster(2).jpg"><img height="239" width="383" border="0" alt="" src="/FileAssets/ContentCast/25/Uploads/FCC_Poster.jpg"></a></p>
<p>Sales into the local South African market constitute less than half of the company's turnover whilst exports, largely to the US but also to Canada, Germany, Australia, Japan, Korea and the UK, make up the remainder. More than 150 Drug
Master Files have been filed worldwide in support of marketing approvals.</p>
<p>The future orientation of the company is strongly directed towards the regulated export markets where effort is focused on developing niche products that will enhance value for the company and its customers. The company is currently
looking at increasing its portfolio of Highly Potent Active Pharmaceutical Ingredients (HPAPI), with significant investment planned in support of these activities. The company currently manufacturer’s cytotoxic compounds, opiates and
various other compounds for a wide spectrum of therapeutic categories. .</p>
<p></p>
<p></p>
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<p></p>
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<p></p>
<p>Following the new approach taken by FDA in October of 1994 with the more rigorous application of cGMPs to offshore API producers, FCC invested heavily in GMP compliance. Facilities were upgraded and a systems approach across the whole
spectrum of the business was taken to bring GMP’s up to the required standard. A variety of US based consultants were used alongside local management to implement the required changes and since then a management structure has been
implemented to ensure ongoing control over cGMP. The effectiveness of this has been indicated by numerous successful customer inspections, including those by major international pharmaceutical companies. In addition, no Form 483 was issued
nor were any adverse findings noted following the last four FDA inspections that took place in July 1996, November 1999, September 2002 and October 2006.<br>
</p>
<p>The production facilities at Fine Chemicals Corporation (FCC) are divided into 10 production buildings and the total production processing area under roof inclusive of mezzanines amounts to 6965m2. The raw materials and finished goods
stores comprise a further 3388m2. The total site area is 2,7ha/27000m2.</p>
<p>A comprehensive, ongoing health, safety and environmental programme has been structured to ensure the safety of employees and compliance with the recent changes in the relevant legislation.</p>
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<h3>Quality Control</h3>
<p> The Quality Control Laboratory function complies fully with cGMPs and is capable of performing virtually all testing in support of the product range.... <a href="Quality-Control.aspx" class="links">read more</a>
</p>
<h3>Environment and Safety</h3>
<p> FCC has in place appropriate Occupational Health, Safety and Environmental (OHSE) policies. The company employs a full time Risk / Loss Control Manager who...<a href="Environment-Safety.aspx" class="links">read more</a>
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</form>Text Content
* * Company History
* cGMP Compliance
* Career Opportunities
* Fraud & Ethics Notice (PDF)
* Terms & Conditions(PDF)
* * Product List
* * Capability
* Operating Ranges
* Multi-purpose Reactor Trains
* Hydrogenation
* Solid / Liquid Separation
* Drying Capabilities
* Milling
* Micronising
* Production Laboratory
* Reaction Capability
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FINE CHEMICALS CORPORATION
The business of Fine Chemicals Corporation was established in Cape Town, South
Africa in 1962. Initially, products including Codeine Phosphate, Morphine
Sulphate and Paracetamol were targeted at the local South African market and in
the mid 1980's a range of off patent generic API's were developed in-house.
These were largely destined for the US market.
Sales into the local South African market constitute less than half of the
company's turnover whilst exports, largely to the US but also to Canada,
Germany, Australia, Japan, Korea and the UK, make up the remainder. More than
150 Drug Master Files have been filed worldwide in support of marketing
approvals.
The future orientation of the company is strongly directed towards the regulated
export markets where effort is focused on developing niche products that will
enhance value for the company and its customers. The company is currently
looking at increasing its portfolio of Highly Potent Active Pharmaceutical
Ingredients (HPAPI), with significant investment planned in support of these
activities. The company currently manufacturer’s cytotoxic compounds, opiates
and various other compounds for a wide spectrum of therapeutic categories. .
Following the new approach taken by FDA in October of 1994 with the more
rigorous application of cGMPs to offshore API producers, FCC invested heavily in
GMP compliance. Facilities were upgraded and a systems approach across the whole
spectrum of the business was taken to bring GMP’s up to the required standard. A
variety of US based consultants were used alongside local management to
implement the required changes and since then a management structure has been
implemented to ensure ongoing control over cGMP. The effectiveness of this has
been indicated by numerous successful customer inspections, including those by
major international pharmaceutical companies. In addition, no Form 483 was
issued nor were any adverse findings noted following the last four FDA
inspections that took place in July 1996, November 1999, September 2002 and
October 2006.
The production facilities at Fine Chemicals Corporation (FCC) are divided into
10 production buildings and the total production processing area under roof
inclusive of mezzanines amounts to 6965m2. The raw materials and finished goods
stores comprise a further 3388m2. The total site area is 2,7ha/27000m2.
A comprehensive, ongoing health, safety and environmental programme has been
structured to ensure the safety of employees and compliance with the recent
changes in the relevant legislation.
QUALITY CONTROL
The Quality Control Laboratory function complies fully with cGMPs and is capable
of performing virtually all testing in support of the product range.... read
more
ENVIRONMENT AND SAFETY
FCC has in place appropriate Occupational Health, Safety and Environmental
(OHSE) policies. The company employs a full time Risk / Loss Control Manager
who...read more
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