BIOSECURE Act and Peptide API Supply: What Is Law and Who Is Building Capacity

The BIOSECURE Act became law in December 2025. What it restricts, what is still pending, and the confirmed peptide manufacturing investments in the US, Europe and India.

By Peptide Briefing · October 20, 2026 · 2 min read

Corrected October 20, 2026. An earlier version of this article, first published June 9, 2026 and based on a trade-press report, cited $3.1 billion in reshoring investment, a rise in North American capacity share from 18% to 28%, a 35–65% domestic cost premium, and investments by Thermo Fisher ($420 million, Greenville) and Recipharm ($180 million, Niagara Falls). We could not confirm any of these against company or government sources and have removed them.

What the BIOSECURE Act Does

The BIOSECURE Act became law on December 18, 2025, as Section 851 of the FY2026 National Defense Authorization Act. It bars federal agencies from contracting with companies that use biotechnology equipment or services from a “biotechnology company of concern” to fulfil a federal contract.

The enacted version is narrower than earlier bills. It does not name companies. Instead, the Office of Management and Budget leads an interagency process to designate them, with an initial list due within a year of enactment, so by December 2026. Until that list exists, no peptide manufacturer is formally designated, and buyers should treat claims that a specific supplier is “banned under BIOSECURE” with caution.

Confirmed Peptide Capacity Investments

  • Bachem plans to invest more than CHF 500 million in its greenfield Sisslerfeld site in Switzerland, under a long-term supply agreement with an undisclosed partner. Commercial production is expected in 2030 (announced July 21, 2026).
  • Cambrex is investing $120 million at Charles City, Iowa, adding about 40% capacity for small molecules and peptides (announced October 2025).
  • CordenPharma acquired AmbioPharm in May 2026, adding the North Augusta, South Carolina peptide site, which AmbioPharm had announced it would expand by 68,000 square feet in March 2026.
  • Neuland Laboratories committed about $30 million to the first module of a commercial peptide facility at its Bonthapally campus in Telangana, India, with 6,370 L of SPPS and LPPS reactor capacity (announced March 2026).

For company-level capacity and deal data, see our peptide CDMO market landscape.

What It Means for Buyers

New capacity takes years to come online. Bachem's Sisslerfeld site is not expected to produce commercially until 2030. If you are diversifying away from a single region, start qualifying an alternative supplier well before you need it, and watch for the OMB list later this year.

References

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