Description
The Department of Veterans Affairs is soliciting offers for Metolazone Tablets. The solicitation requires offerors to provide information on their manufacturing facilities, including the location and FDA establishment identification number. The contract will be awarded to a company that can provide the required pharmaceutical products, and the contractor must comply with FDA regulations and guidelines. The offeror must also provide documentation to substantiate the certified country of origin and the location of manufacturing processes.
Key points to consider:
• The offeror must have an acceptable cGMP status on record with the FDA for the facilities identified.
• The contractor shall use only the FDA-inspected manufacturing facilities provided for the duration of the contract.
• 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 Government will evaluate the country of origin of offered pharmaceutical products to determine if the proposed products are U.S.-made or designated country end products.