FDA approves Omega Laboratories for manufacturing

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Besiki Kavtaradze)
(Image: Getty/Besiki Kavtaradze)

Related tags: Omega Laboratories, Sagent, Nichi-Iko, Naloxone

Sagent announces the approval of its subsidiary’s facility in Canada to manufacture small molecule drug products for the US market.

Sagent Pharmaceuticals, a subsidiary of the Japanese pharmaceutical Nichi-Iko, acquired Omega Laboratories in 2014, through an $83.5m (€75.6m) cash deal to expand its portfolio of generic injectables.

Following an inspection at Omega’s facility in Montreal, Canada, the US Food and Drug Administration (FDA) approved the site to manufacture small molecule drug products, including aminoglycosides, hemostatics and opiate antagonists, such as naloxone.

The site will provide Sagent with up to 30 million vials of internal manufacturing capacity annually, ‘significantly’ expanding the company’s ability to market its products on the US market, according to the company.

With this approval, Omega’s manufacturing site becomes the second FDA-approved facility owned by the Nichi-Iko group, after Sagent’s acquisition​ of Xellia’s site in Raleigh, North Carolina, earlier this year.

Yuichi Tamura, CEO of Nichi-Iko, said that Omega’s manufacture capability is expected to boost the overall business’ 'patient-centric' offering of generic products.

Nichi-Iko acquired​ Sagent​ for $736m in 2016, to establish its footprint in North America and boost its generics and biosimilars sales in the US market.

Related topics: Globalization, Drug Delivery, Regulations

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