A US District Attorney in Massachusetts requested documents on production at the Danish facility, which makes insulin products, GLP-1 (Glucagon-like peptide-1 for diabetes biologic Victoza), and Factor 7 for haemophilia.
Novo Nordisk spokesman Mike Rulis told in-Pharmatechnologist.com the company does not know which of its manufacturing units at Kalundborg are implicated by the filing.
“At this point in time the scope and reason for the subpoena is not entirely unclear. The exact [motive] will be determined in the months ahead in meeting with the District Attorney.”
Reuters reported that the same District Attorney issued a subpoena in 2011 relating to Novo Nordisk’s marketing and promotion of diabetes drugs – a case that is ongoing.
“Experience tells that these things take a long time – several years – but exactly how long we really can’t say – neither can we say when we will have new information of relevance,” said Rulis.
He added that it is “very, very unlikely” the legal issues will cause manufacturing delays.
The company says it is “co-operating fully” with the investigation and is “confident in the safety of its products.”