Pronova Biopharma granted GMP certification in Denmark

30-Sep-2009 - Norway

Pronova BioPharma ASA announced that the Danish Medicines Agency (Lægemiddelstyrelsen) has recently inspected new manufacturing facility in Kalundborg, Denmark and granted the company a GMP (good manufacturing practice) certificate.

The GMP certificate from the Danish Medicines Agency verifies compliance with the GMP guidelines. The GMP guidelines are intended to ensure that the active pharmaceutical substance manufactured has the quality and purity it is represented to possess. The Agency will, at Pronova BioPharma's request, conduct periodic inspections at the facility to ensure continued compliance.

"The GMP certificate marks another important milestone for the company's new manufacturing plant in Kalundborg. The remaining regulatory approvals are expected to be achieved early in 2010, in order for the first commercial shipments to take place in Q1" said Kjetil Olsen, senior vice president supply chain.

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