6505--Pioglitazone Tablets

This solicitation seeks a firm‑fixed‑price, indefinite‑delivery contract to supply Pioglitazone HCL tablets in three dosage strengths (15 mg, 30 mg, 45 mg) and three package sizes (30‑tablet, 90‑tablet, 500‑tablet bottles) to the VA, DoD, IHS, and BOP. The contractor must meet stringent FDA cGMP, labeling, packaging, barcode, and DSCSA serialization requirements, provide unique 11‑digit NDCs (and ANDA numbers where applicable), and include a 0.5 % cost‑recovery fee in unit prices. The award will be a single aggregate contract covering nine line items for a base year plus four one‑year options (total possible term 5 years). Quarterly sales reporting and fee remittance are required, and subcontracting plans are mandatory for contracts exceeding $900 k. • Deliver up to 177,540 bottles per year across nine product configurations. • Must use plastic bottles with safety caps, specific label dimensions, and barcodes encoding NDC/GTIN. • Requires FDA‑approved NDA/ANDA, cGMP compliance, and a Letter of Commitment if the offeror is not the manufacturer.