How solvent bans and US security laws reshape supply
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
API-specific; process solvents DMF and NMP are reproductive toxicants (Repr. 1B)
API not regulated; DMF UN2265
Solvent exposure in plants; TFA is corrosive.
Main rules
Where
Rule
Effect
EU
REACH restriction on DMF (Dec 2023) and NMP (2020) setting exposure limits
drives solvent substitution in SPPS
US
BIOSECURE Act (Dec 2025); FDA guidance on synthetic peptide ANDAs referencing rDNA origin (2021)
affects outsourcing choices and generic entry
India
Rule
Effect
CDSCO approval of generic GLP-1s; patent expiry March 2026 (indicative)
opens domestic market
PLI for pharmaceuticals (Rs 15,000 crore) covers complex generics and peptides
incentive for complex APIs (indicative)
Trade measures
US 1260H listing of WuXi AppTec (June 2026), preliminary injunction (Aug 2026)
Supply risk
Capacity is concentrated in a few CDMOs and originator plants; GLP-1 shortages in 2022-2024 showed supply could not keep up with demand.