EU regulators approve Pronova plant in Denmark

Published: 25-Nov-2009

The EU regulatory authorities have approved Pronova BioPharma's new manufacturing plant in Kalundborg, Denmark. Approval from the US Food and Drug Administration is expected in the second half of 2010.


The EU regulatory authorities have approved Pronova BioPharma's new manufacturing plant in Kalundborg, Denmark. Approval from the US Food and Drug Administration is expected in the second half of 2010.

Pronova BioPharma is a specialist in marine-originated omega-3 derived pharmaceutical products. Its first commercialised product is branded as Omacor in Europe and Asia and as Lovaza in the US.

The drug is prescribed as a dietary supplement for the treatment of hypertriglyceridemia (HTG), a form of dyslipidemia (or disorder of lipid metabolism).

The product is manufactured at the company's plant in Sandefjord, Norway.

The company says commercial deliveries will start from the Kalundborg plant in the first quarter of 2010.

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