Omnichem expands in high-demand API market
Omnichem is increasing its Class V handling capabilities with an
expansion of their facility in Louvain-la-Neuve, Belgium.
The new facility will add 4,800 litres to its high potency active pharmaceutical ingredient (API) manufacturing capacity in the form of two segregated production lines, each with vessels of 800 and 1,600 litres and occupational exposure limits (OEL) down to 0.1 µg/m3.
"We expect our new plant to be fully operational by early 2007," Thierry Van Nieuwenhove, Fine Chemicals Business Manager, >Omnichem told In-PharmaTechnologist.com.
"This extra facility will enable Omnichem to manufacture medium to large quantities of Class V compounds, offering batch sizes in excess of 100 kg," he said.
The manufacture of high-potency APIs has become an attractive niche sector for custom manufacturers, such as Omnichem, as generating double-digit sales growth.
Pharmaceutical companies are increasingly recognising the benefits of outsourcing research and development to and in particular there has been a continual increase in demand for custom chemical manufacturing services for highly potent APIs.
The latest expansion by Omnichem aims to compete with the current trend among contract manufacturing organisations to tap into niche markets such as this one, due to an overcapacity in the marketplace.
The number of recent investments in this area have led some industry observers to suggest that competing in this sector may soon become a challenge.
Sigma-Aldrich Corporation (SAFC) is currently undergoing a major expansion at its Madison, Wisconsin, facility with construction of a new facility aimed at manufacturing of highly potent APIs. The facility should be complete in early 2006.
Switzerland's Helsinn has been constructing a small-scale API facility targeted towards supplying clinical trial materials in the 0.1 to 0.5 kg range, which will come on-line by the end of 2005 and also a large-scale production bay for large batches (10-50 kg) that should be ready in 2006.
Another Swiss company, Lonza has boosted its ability to make APIs at its Visp site, with production also expected in 2006.
US firm Solutia has also expanded its high potency portfolio with the commissioning of a production facility designed to operate at or below 0.3mg/m3. This unit is geared up to cater for cytotoxics and other materials up to Category 4. It has also added two 2,500-litre reactors to its capabilities.
Omnichem is a multinational company based in Belgium that has been active in the high containment field for more than 30 years.
