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news.Bentley Pharmaceuticals has said that its European subsidiaries have received approvals to market their omeprazole capsule products, through their licensees, in various territories in Europe.
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The approvals are for 10mg, 20mg, and 40mg dosage levels of omeprazole capsules under a mutual recognition procedure (MRP) that grants simultaneous authorizations throughout the EU. Bentley’s subsidiaries expect to supply omeprazole to their licensees in the major markets of Germany and Italy, as well as other EU countries.
The manufacture and supply of the finished products will be through Bentley’s subsidiary, Laboratorios Belmac. The company plans to begin supplying omeprazole to licensees during the first quarter of 2008.