Lianyungang Guike: EU shuts out its atracurium and cisatracurium
A Belgian inspection for EDQM found a critical cross-contamination gap at this Chinese API plant. EDQM suspended all its CEPs, and Hetero's entecavir certificate fell with them.
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Products at risk. Who's in.
CEP suspendedEDQM suspended the certificate
| MOLECULE | FORM | SOLD IN THE EU BY | LINK TO SITE | RISK | WHO'S IN | Action |
|---|---|---|---|---|---|---|
| Atracurium besilate | API | Not disclosed | CEP SUSPENDED | CEP SUSPENDED | 11 API (4 CEP) | See who's in |
| Cisatracurium besilate | API | Not disclosed | CEP SUSPENDED | CEP SUSPENDED | 10 API (0 CEP) | See who's in |
| Entecavir | Intermediate for the Hetero Drugs CEP | Hetero Drugs (CEP holder) | CEP SUSPENDED | CEP SUSPENDED | 20 API (2 CEP) | See who's in |
"Who's in" counts manufacturers of the same molecule in the API-FDF database; the number in brackets holds a CEP. Names and contacts are inside.
What EU regulators found
- Belgian inspectors, working in EDQM’s inspection programme, listed 21 GMP deficiencies after a June 2026 visit. One was critical.
- The critical one: weak control of contamination and cross-contamination in Workshop 2 and the dispensing area, where shared equipment also handles potentially highly potent products.
- EDQM suspended every CEP the site held. That includes the entecavir CEP of Hetero Drugs, because Guike makes the intermediate.
- Regulators asked marketing authorisation holders to remove or replace Guike as API source. No new EU approvals may rely on it.
Timeline
How it got here
12 JUN 2026
Inspection ends
27 JUL 2026
EDQM suspends the atracurium, cisatracurium and entecavir CEPs
21 AUG 2026
Belgium issues the statement of non-compliance
NEXT
Re-inspection before any CEP is restored