Suppliers / Bioiberica, S.A.U

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
active US DMFs
0
valid CEPs
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
Plants
2 of 2 confirmed
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 1000418405
Spain, Spain 3007422507

What they file, and where

Molecule Regulators Docs
Heparin Sodium US FDA 3
Ｈｅｐａｒｉｎｓｏｄｉｕｍｊｐ PMDA (Japan) 1

Also appears on these molecule pages

Heparin API

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

Questions about Bioiberica, S.A.U

Does Bioiberica, S.A.U hold a US DMF or a CEP?
Bioiberica, S.A.U holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Bioiberica, S.A.U FDA-registered?
2 sites operated by Bioiberica, S.A.U carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Bioiberica, S.A.U's last inspection go?
The most recent inspection on record closed on 20 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 1 closed as OAI.
Where does Bioiberica, S.A.U manufacture?
3 registered sites are on record, in Spain (Barcelona and Spain among others). Every site is listed on this page with the register it came from.
What does Bioiberica, S.A.U make?
2 molecules are on record against Bioiberica, S.A.U, including Heparin Sodium and Ｈｅｐａｒｉｎｓｏｄｉｕｍｊｐ. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bioiberica, S.A.U's GMP?
Current GMP certificates are on record from AEMPS (ES) and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was VAI, on 20 September 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates