Sagent Pharmaceuticals gets FDA clearance for Omega manufacturing site
6 September 2019 -

Sagent Pharmaceuticals Inc said on Thursday that its Canadian subsidiary Omega Laboratories Limited has received approval for the manufacturing of US Food and Drug Administration (FDA)-approved products under the FDA's initial Establishment Inspection Report.

Based in Montreal, the Omega site is approved to manufacture small molecule products. It becomes the second FDA-approved facility in the Nichi-Iko Group network.

The Omega site reportedly provides Sagent with up to 30 million vials of annual internal manufacturing capacity, significantly expanding its ability to deliver products consistently to patients across the US.

Sagent Pharmaceuticals is focused on developing, manufacturing, sourcing and marketing pharmaceutical products for the North American market. It is part of Nichi-Iko Group Company, one of the largest generic drug manufacturers in Japan by sales.