# Custom synthesis (CDMO): Regulation

Potent compounds, multipurpose plants and the rules that keep them safe

Source page: https://www.materialinsights.org/chemicals/custom_synthesis/regulation/

What this tab covers How it is regulated and what could disrupt supply: hazard classification, rules in the EU, US and India, anti-dumping duties and other trade measures, and supply-risk notes.

#### Hazards

| Classification | UN number | Key risks |
|---|---|---|
| product-specific | product-specific | Process safety in multipurpose plants, containment of potent compounds, data integrity. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **US** | BIOSECURE Act (FY2026 NDAA, signed 18 Dec 2025): bars federal procurement, contracts and grants involving biotechnology companies of concern; OMB list due Dec 2026; grandfathering for 5 years | pushes US customers to diversify from WuXi |
| **US** | DoD 1260H list: WuXi AppTec added 8 June 2026 (after a brief Feb 2026 listing withdrawn the same day); preliminary injunction granted 7 Aug 2026 by the US District Court for the District of Columbia | legal uncertainty |
| **EU and US** | GMP inspections, data integrity (ALCOA) | inspection outcomes decide access |

#### India

| Rule | Effect |
|---|---|
| **Revised Schedule M GMP; CDSCO; USFDA inspections of Indian sites** | quality gate for CDMO work |
| **PLI for pharmaceuticals (Rs 15,000 crore) and Promotion of Research and Innovation in Pharma (PRIP)** | support for complex manufacturing and R&D (indicative) |
| **Patents Act and trade secret protection** | IP security is a key customer concern |

#### Trade measures

- US BIOSECURE Act (2025)
- US Section 232 investigation on pharmaceuticals (2025)

#### Supply risk

Innovator supply chains rely heavily on WuXi and a few Western CDMOs. A forced exit from Chinese CDMOs would take years because of tech transfer and re-validation.

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/custom_synthesis/index.md)
- [Overview](https://www.materialinsights.org/chemicals/custom_synthesis/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/custom_synthesis/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/custom_synthesis/routes/index.md)
- [Production](https://www.materialinsights.org/chemicals/custom_synthesis/production/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/custom_synthesis/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/custom_synthesis/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/custom_synthesis/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/custom_synthesis/movement/index.md)
- [Characteristics](https://www.materialinsights.org/chemicals/custom_synthesis/characteristics/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/custom_synthesis/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/custom_synthesis/links/index.md)