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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 more