PHARM MANUF/DISTR DIV - FSA

The solicitation SPE2D2-26-R-0011 seeks bids for the supply of Valsartan tablets in multiple strengths and packaging configurations under a Lowest Price Technically Acceptable (LPTA) source selection process. Offerors must provide FDA-compliant pharmaceuticals manufactured in cGMP facilities, with unit-of-use packaging meeting strict specs including child-proof closures, 100cc cylindrical bottles with a minimum 5.75-inch circumference, and label dimensions of 5.25" × 2", excluding glass containers. Mandatory barcoding at the unit level must comply with GS1-128, HIBCC, or UPC standards, encoding the NDC, lot number, and expiration date, with print quality meeting ANSI/ISO/IEC Grade C, and placement rules requiring visibility on each blister cell and avoidance of perforations. Proposals must demonstrate technical acceptability in compliance with packaging, labeling, and manufacturing standards, as well as an acceptable past performance rating, with award going solely to the lowest-priced technically qualified offeror. The contract includes a one-year base period with four one-year options, spanning up to five years, and requires binding business agreements with Prime Vendor contractors, through whom payment is exclusively processed, with no direct government invoicing permitted. All offerors must register in SAM.gov, hold a Unique Entity Identifier, and submit completed representations and certifications via DIBBS, including disclosures regarding country of origin for active pharmaceutical ingredients, affirmative compliance with DFARS 252.204-7018 on covered telecommunications equipment, and small business status if applicable. A signed Letter of Commitment from an authorized corporate officer is required, affirming uninterrupted supply and full disclosure of manufacturing locations. Proposals must be divided into two electronic volumes: non-price documentation including SF 1449, FDA disclosures, and subcontracting plans for large businesses, and a separate price volume for all CLINs, submitted through DIBBS by July 23, 2026. Inspection occurs at manufacturing sites, with ongoing compliance monitored under FDA 21 CFR Part 210/211, and failure to maintain cGMP standards can lead to termination. Performance will be tracked via CPARS for contracts over $350,000, and delivery must occur within 15 calendar days of order issuance to PPV contractors. No government payment office is involved; all compensation flows through prime vendors under business-to-business arrangements,