Manufacturing pharmaceutical preparations and medications for VA, DoD, and IHS drug programs. Find active federal and state pharmaceutical preparation manufacturing contracts — AI-scored against your profile across SAM.gov and 200+ portals.
Annual federal spend under NAICS 325412 exceeds $2 billion, driven primarily by VA, DoD, and IHS drug programs. Competition is moderate; top contracts are often IDIQs or BPAs with guaranteed minimums. Demand spikes with public health emergencies and new drug approvals. Contracts are typically multi-year, fixed-price with incentive fees for performance. The market is consolidated among large manufacturers, but small businesses can compete via set-asides for generic drugs and specialized compounds.
These agencies are the largest buyers of pharmaceutical preparation manufacturing services and products in the federal government. Each awards contracts under NAICS 325412 regularly — build relationships with their small business offices first.
Winning contracts in 325412 requires FDA registration and cGMP compliance. Most set-asides are 8(a) and SDVOSB for VA and DoD. The highest-leverage move is to secure a GSA Schedule 65 IIA contract, which allows agencies to order directly. Focus on a narrow therapeutic category (e.g., oncology injectables) to differentiate from large manufacturers. Partner with a prime on a major IDIQ like TRICARE or VA National Formulary.
Most pharmaceutical contracts use LPTA for generics and best-value for complex formulations. Common vehicles include GSA Schedule 65 IIA, VA's NAC IDIQ, DoD's TRICARE pharmacy contract, and NIH's Pharmaceutical Support Services BPA. Evaluation often emphasizes past performance, FDA compliance history, and price per unit.
You must have an active FDA establishment registration and list your drug products with the National Drug Code (NDC). For controlled substances, DEA registration is also required. Most RFPs require proof of current Good Manufacturing Practice (cGMP) compliance.
Yes, for contracts over $150,000, Miller Act bonds (bid, performance, and payment) are typically required. For IDIQ orders, bonding may be waived if the guaranteed minimum is below the threshold. Check each solicitation's bonding clause.
VA and DoD prioritize SDVOSB and VOSB certifications. 8(a) and HUBZone are also common set-asides. For NIH contracts, having a Small Business Innovation Research (SBIR) award can provide a competitive edge.
Highly competitive among small businesses, but less so than open market. For example, VA's SDVOSB set-aside for generic drugs often receives 5-15 offers per solicitation. Specialization in a niche drug type reduces competition.
For small business set-asides, average award size is $2-10 million over 3-5 years. Larger IDIQs can have ceilings of $100 million, but small businesses typically win task orders in the $500k to $5 million range.