Nichi-Iko Pharmaceutical and Sagent Pharmaceuticals announced their Canadian subsidiary, Omega Laboratories, has been found acceptable for manufacturing FDA-approved products in its initial Establishment Inspection Report issued by the U.S. FDA.
Omega, based in Montreal, Canada, is approved to manufacture small molecule products, and becomes the second FDA-approved facility in the Nichi-Iko Group network. The site provides Sagent with up to 30 million vials of annual internal manufacturing capacity, significantly expanding the Group's ability to deliver products consistently to patients across the U.S.
"We are excited to announce the successful completion of our Omega expansion project," said Dr. Peter Kaemmerer, Chief Executive Officer of Sagent. "The acceptance of our facility to manufacture small molecule products for the US market continues the transformation of Sagent that began with the acquisition of the Raleigh manufacturing site earlier this year. The addition of Omega as an FDA-approved site further enhances our developing internal manufacturing capabilities, which will remain a complement to our historic partner-based supply model."
"We welcome the acceptance of Omega's manufacturing line by the U.S. FDA,” Yuichi Tamura, President and CEO of Nichi-Iko said. “Omega's ability to manufacture products for the U.S. market will help to accelerate the achievement of our mission to deliver a patient-centric experience, providing value-added, high quality generic products."