API RED LIST Who's out. Who's in.
EU NCR · 21 SEP 2026CEP SUSPENDEDNCR FIMEA/2026/003795 · Xi’an

Xi’an Guokang Ruijin: four steroid CEPs suspended at once

Finnish inspectors on an EDQM mission found 11 major GMP gaps at this Chinese steroid plant, including the risk that non-GMP API reached medicine makers. EDQM suspended four CEPs.

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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
Dexamethasone API: sodium phosphate, crystalline forms A and B Not disclosed CEP SUSPENDED CEP SUSPENDED 31 API (5 CEP) See who's in
Betamethasone API Not disclosed CEP SUSPENDED CEP SUSPENDED 43 API (8 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
  1. The June 2026 inspection, run for EDQM, grouped 18 deficiencies against EU GMP. Eleven were major.
  2. Quality assurance oversight was inadequate, and the intermediates plant had design, cleaning and contamination-control gaps.
  3. Solvent recovery lacked traceability and carried a cross-contamination risk.
  4. Inspectors flagged a risk that APIs made outside GMP were supplied for human or veterinary medicines. Data integrity and change control also failed.
Timeline

How it got here

12 JUN 2026 Inspection ends
29 JUL 2026 EDQM suspends four CEPs: dexamethasone sodium phosphate, dexamethasone forms A and B, betamethasone
21 SEP 2026 Finland issues the statement of non-compliance

Guokang is out. 31 dexamethasone API makers are in.

Open the list on API-FDF

Sources