For immediate release
Ropack Compliant with Generic Drug User Fee Amendment of 2012
Ropack Inc, provider of primary and secondary packaging services to the branded and generic drug industry, has submitted identification information to FDA as required by the Generic Drug User Fee Amendments of 2012 (“GDUFA”). Ropack has also contributed to the program through payment of the fiscal 2013 Foreign FDF facility user fee. The Generic Drug User Fee is mandatory for all sites and companies that package or label finished dosage form of a drug into its primary containers or closure system.
The Generic Drug User Fee Amendment of 2012 (GDUFA) is designed to speed access to the public of safe and effective generic drugs and reduce costs to the industry. The law requires industry to pay user fees to FDA to supplement the costs of reviewing generic drug applications and inspecting facilities. Additional resources will enable the Agency to reduce a current backlog of pending applications, cut the average time required to review generic drug applications for safety, and increase risk-based inspections.
GDUFA will also enhance global supply chain safety by requiring that generic drug facilities and sites around the world self-identify.
Please note that if a domestic and/or foreign CMO which meets the GDUFA definition for the mandatory fee but refuses to participate in the Generic Drug User Fee Program, entry to the US market of all products manufactured or packaged at its facility will be denied.
“Ropack is committed to adhering to all regulations and, more importantly, we support all efforts which move our clients’ products to market more quickly and safely,” notes Paul Dupont, Director of Business Development for Ropack.
Ropack, a contract packaging and manufacturing provider for the pharmaceutical and consumer health-careindustries, offers turnkey primary and secondary packaging of solid oral dosage. Ropack operates ambient and refrigerated manufacturing, packaging and warehousing space, providing temperature-monitored distribution services to wholesale distribution networks, physicians and clinical study sites in Canada and the U.S. Facilities are cGMP compliant, Health Canada certified, FDA site-licensed and hold a Natural Health Product license.