Suppliers / Abbott Biologicals

Abbott Biologicals

Netherlands Updated 9 July 2026

Abbott Biologicals is a finished-dose manufacturer based in Netherlands. It appears in 35 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR), INVIMA (CO) and ARCSA (EC). Its GMP standing is certified by ANVISA (Brazil), EMA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 20 April 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
35
filings across 6 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 20 April 2022 VAI US FDA
  • 9 May 2017 NAI US FDA
  • 9 June 2015 NAI US FDA
  • 12 June 2013 VAI US FDA
  • 7 July 2009 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
8121 AA Olst, United Arab Emirates Not on file
OLST, Netherlands Not on file
Weesp, Netherlands Not on file
Netherlands, Netherlands 3000268812

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 12 None
INVIMA (CO) 8 None
ARCSA (EC) 8 None
RAMA (GE) 3 None
NAFDAC (NG) 2 1
MPA (SE) 2 None
ANVISA (Brazil) None 6
EMA None 1

Questions about Abbott Biologicals

Does Abbott Biologicals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Abbott Biologicals. It does have 35 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Abbott Biologicals FDA-registered?
One site operated by Abbott Biologicals carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Abbott Biologicals's last inspection go?
The most recent inspection on record closed on 20 April 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Abbott Biologicals manufacture?
4 registered sites are on record, in United Arab Emirates and Netherlands (8121 AA Olst, Olst and Weesp among others). Every site is listed on this page with the register it came from.
Which regulators recognise Abbott Biologicals's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA and NAFDAC (NG). 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 April 2022.

Comparable suppliers

ACE Pharmaceuticals also in Netherlands Delpharm Meppel also in Netherlands Dsm Anti Infectives also in Netherlands Eurodrug Laboratories also in Netherlands N.V. Organon; also in Netherlands

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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