6505-- Denosumab Injections

The Department of Veterans Affairs is soliciting offers for Denosumab Injections. The solicitation requires offerors to provide information about their manufacturing facilities and compliance with FDA cGMP standards. The contract will be awarded to a company that can provide the required products and meet the FDA cGMP standards. The scope of the contract includes the manufacture and delivery of Denosumab Injections. • The offeror must have an acceptable cGMP status on record with the FDA for the facilities identified in the offer. • The offeror must provide documentation of the correction plan and notification from the FDA of acceptance of the plan. • The offeror must maintain the same manufacturer for the duration of the contract period, unless the Contracting Officer makes a determination that a change in the manufacturer is acceptable. • The offeror must provide sufficient supporting documentation to substantiate the certified country of origin and the location of manufacturing processes.