Clariant produces intermediates and building blocks in India

Clariant Pharmaceutical's Roha/Thane facility near Mumbai in India has successfully produced commercial quantities of intermediates and advanced building blocks for pharmaceutical manufacture, including complex building blocks for statin manufacture.

'Clariant is the only major supplier to the pharmaceutical industry with an integrated India-based facility providing high-value intermediates and starting materials,' said Dr Ralf Pfirmann, global director, pharmaceutical market management for Clariant Pharmaceuticals. 'We are delivering the reliability, quality and confidentiality of a Western supplier with factor costs typical of the Indian market.'

Meanwhile, the company's Isso plant in Italy has successfully completed a US FDA audit and will now manufacture APIs and other regulated materials for the US market. Production of APIs for the US is scheduled to begin in the last quarter of 2003.

Two major developments of Clariant's US facilities have also been announced. At Springfield, Missouri, the company is expanding its Molecules Synthesis Centre (MSC), which provides support to drug discovery and development programmes with manufacturing capabilities from 5 to 200 kilogram levels. The expansion will meet increased demand from North American customers for early phase materials, including development, Phase I and Phase II clinical trials.

Clariant's organometallics capacity at Springfield is also being enlarged. The expansion features lithium technology and low temperature capability on a large scale for commercial production of organometallics, and includes an 8000 litre reaction train capably of producing as much as 300 tonnes of material a year under cGMP conditions. A wide range of commercial scale organometallics, including boronic acids, will be available at the site.

Finally, Clariant Pharmaceuticals is undertaking a new initiative focusing on using microreactor technology (MRT) for specialised chemical synthesis requirements. These include applications that require rapid scale-up, those that have potential safety issues at traditional scales, and reactions that require an uncommonly high level of control or high purity.

'Microfabrication techniques and scale-up by replication are rapidly revolutionising biological research and drug discovery,' said Pfirmann. 'We see many of these advantages becoming possible for the chemical manufacturing side of the pharmaceutical industry.

'Initially we are recommending MRT as a potential solution for customers who have highly exothermic or endothermic reactions or unstable intermediates. It can also be used to solve problems of low selectivity and yield and as an alternative solution for processes that have extensive purification requirements.'