OCB Pharmaceutical: bismuth API from outside EU GMP, repacked in Spain
Catalan inspectors found OCB repacking and relabelling bismuth subsalicylate from a Chinese plant outside EU GMP. Sales of every API from the site are suspended, and the bismuth subnitrate CEP went in November.
Is your product on this list?
Products at risk. Who's in.
In the NCRnamed in the EU non-compliance report CEP suspendedEDQM suspended the certificate
| MOLECULE | FORM | SOLD IN THE EU BY | LINK TO SITE | RISK | WHO'S IN | Action |
|---|---|---|---|---|---|---|
| Bismuth subsalicylate | API | Not disclosed | IN THE NCR | SALE SUSPENDED | 7 API (0 CEP) | See who's in |
| Bismuth subnitrate | API | Not disclosed | CEP SUSPENDED | CEP SUSPENDED | 12 API (1 CEP), all bismuth salts | 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
- The August 2026 inspection found nine deficiencies: one critical, eight major.
- The critical one: OCB repackaged, relabelled and distributed bismuth subsalicylate from a Chinese manufacturer working outside the EU GMP framework.
- The NCR also names bismuth citrate, subcitrate, subgallate, subnitrate, subcarbonate, oxide, tribromophenate and sodium bismuth tartrate.
- Catalonia temporarily suspended all API and intermediate manufacturing at the site. Its EU GMP certificate was withdrawn.
Timeline
How it got here
27 AUG 2026
Inspection ends
28 SEP 2026
Statement of non-compliance; API sales and manufacturing suspended
2 NOV 2026
EDQM suspends the bismuth subnitrate CEP