Omega Laboratories Limited, a Canadian-based subsidiary of Nichi-Iko Pharmaceutical Co., Ltd., and Sagent Pharmaceuticals, Inc., recently passed its initial Food and Drug Administration (FDA) Establishment Inspection Report and will now be allowed to manufacture FDA-approved products.
Omega will focus primarily on the manufacturing of small-molecule products.
"We are excited to announce the successful completion of our Omega expansion project," Dr. Peter Kaemmerer, chief executive officer of Sagent, said in a press release. "The acceptance of our facility to manufacture small-molecule products for the U.S. 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."
Omega is Nichi-Iko Group’s second FDA-approved facility and is able to produce 30 million vials of annual internal manufacturing capacity.
"We welcome the acceptance of Omega's manufacturing line by the U.S. FDA,” Yuichi Tamura, president and CEO of Nichi-Iko, said in the release. “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."
