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news.Rhodia Pharma Solutions has signed a long-term supply agreement with Critical Therapeutics to manufacture active pharmaceutical ingredients for asthma treatment zileuton at its facility in Scotland. Critical Therapeutics' shares have risen over 7% on the news.
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Rhodia Pharma Solutions will be responsible for the manufacture of active pharmaceutical ingredients used in the production of various formulations of zileuton, including Zyflo filmtab (zileuton tablets), which received marketing approval from the FDA in 1996 for the treatment of asthma in patients 12 years of age and older.
Critical Therapeutics owns worldwide marketing and development rights to numerous formulations of zileuton.
Rhodia’s site in Annan, Scotland is a validated cGMP facility for the manufacture of both pharmaceutical intermediate and active pharmaceutical ingredients. Rhodia has already produced quantities of Critical Therapeutics’ zileuton at both its Annan and Dudley, UK sites. When zileuton manufacturing is consolidated in Annan, it will represent one of the site’s major activities.
“This supply agreement is designed to ensure that Critical Therapeutics has adequate bulk drug inventories to meet anticipated clinical and commercial demand for zileuton,” said Dr Paul Rubin, president and CEO of Critical Therapeutics.