Pharmaceutical Technologist - November 2007 - (Page 36)

GLOBAL KNOW-HOW Serving the world Profile: Dishman Pharmaceuticals and Chemicals Ltd Contract research and manufacturing services (CRAMS) is a favoured model among many Indian pharmaceutical companies. Some have added these activities to their core business alongside development, realizing its potential for outsourcing to the West. Others established their companies with CRAMS from the onset. Take Dishman Pharmaceuticals and Chemicals Ltd (Ahmedabad), one of India’s largest companies. Since its establishment in 1989, the company’s managing director, J.R. Vyas, has taken a unique approach compared with other local manufacturers. “Most of the companies here went after generic APIs, then generic formulations,” he explains. “The awareness for CRAMS has risen later, in particular for midsized companies. But opportunities lay for this size of companies: the model will become stronger and stronger in the years to come as Big Pharma companies who can also do it have already put their priorities somewhere else, such as in formulations, creating their own field forces in Europe and the US, and getting better value from their formulated products.” With a strong base in specialty chemicals and a solid R&D backbone established following a $100 million investment, Dishman can help formulators develop compounds on scales from grams to tons. But the unusual aspect of the company’s model is its strong noncompetitive dimension — the company is not a generic player. “We are a pioneer in the CRAMS profile and have to create our own structured models,” explains Vyas. “We are not into generic APIs although we are producing intermediates and have the capabilities to develop generic products when required. So we have a technology transfer division where we develop technologies for our customers, license them for a small fee, but offer to our clients the possibility to enter a supply agreement for the intermediates. This is both an innovative and contract manufacturing agreement model.” Dishman expanded to the global market by acquiring in 2006 Carbogen-Amcis, a Swiss research company with three production facilities in Switzerland. The acquisition boosted Dishman’s contract manufacturing business, allowing it to become the only contract manufacturing organization in India with high-potency manufacturing capability. “The model we are now offering is interesting as there would be one project manager, and absolute seamless development,” says Vyas. “If it is a large tonnage product, we also offer our US FDA facilities in India, and can provide the customers with tailor-made development solutions. When an innovator works with someone such as Carbogen, up to preclinical Phase I, they will want someone willing to do a very fast job for a few grams. After Phase I, when the biovalidity and the dosage is known, and the customer is deciding the target price for the API, that’s when they start looking for the company that can improve upon the process. This is where we come into the picture. In Phase II, cost optimization becomes essential. India is the best location for that, as cost structure is optimal. You can, therefore, commit many chemists to be able to work this optimization at best. You need hundreds of experiments to find the best routes for your production, and the cost structure here makes it possible under the best conditions.” While looking for additional opportunities in the US and Europe, Dishman is also venturing into API production in Saudi Arabia and considering options in Africa. Dishman has established a sales presence in Japan as well. “Today, 90% of our business is generated around the world with 10% in the US, but with our acquisition of Carbogen-Amcis, we expect deeper changes,” said Vyas. PT J.R. Vyas 36 November 2007 l pharmaceutical technologist http://www.ecreviews.com

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Pharmaceutical Technologist Contents Editor's Comment News Morpheus Feeling the Pressure Legal Crusaders The Holy-Grail of Start-Up Biotech Special Feature Q&A

Pharmaceutical Technologist - November 2007

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