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.