Bioiberica, S.A.U
Spain Updated 9 July 2026
Bioiberica, S.A.U is an API manufacturer based in Spain. It holds 3 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with MINSA (CR) and INVIMA (CO). Its GMP standing is certified by AEMPS (ES) and US FDA. Its most recent recorded inspection, by US FDA, closed on 20 September 2024 as VAI.
3
registered plants
2 with an FDA FEI number
4
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 20 September 2024 VAI US FDA
- 16 February 2023 VAI US FDA
- 4 February 2022 OAI US FDA
- 17 December 2019 VAI US FDA
- 21 September 2018 VAI US FDA
- 17 November 2017 VAI US FDA
- 28 May 2015 VAI US FDA
- 28 May 2015 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Barcelona, Spain | Not on file |
| Spain, Spain | 3007422507 |
| Spain, Spain | 1000418405 |
What they file, and where
| Molecule | Regulators | Docs |
| Heparin Sodium | US FDA | 3 |
| Ｈｅｐａｒｉｎｓｏｄｉｕｍｊｐ | PMDA (Japan) | 1 |
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| MINSA (CR) | 3 | None |
| INVIMA (CO) | 1 | None |
| AEMPS (ES) | None | 2 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 20 September 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates