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EU approves firms’ generic omeprazole


Specialty drug company Bentley Pharmaceuticals has announced that its European subsidiaries have received approvals to market omeprazole capsule products, via licensees, in various territories in Europe.

The approvals are for 10mg, 20mg and 40mg dosage levels of omeprazole capsules under a Mutual Recognition Procedure (MRP) that grants simultaneous authorisations 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.

Omeprazole is marketed in the USA as Prilosec® by AstraZeneca and as Losec® in Europe.

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.

Bentley chairman and CEO Jim Murphy said: “Representing our first product entry into the major European markets of Germany and Italy, these approvals follow the November 2007 announcement of our entrance into France by way of similar agreements to distribute lansoprazole.

“We expect that these MRP approvals, together with other MRP registrations pending, will grow our specialty generic revenues outside of Spain by approximately 25% in 2008.”

Bentley Pharmaceuticals

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