Suppliers / Abbott Laboratories

Abbott Laboratories

United States 8 duplicate records merged Updated 9 July 2026

Abbott Laboratories is a finished-dose manufacturer based in United States. It appears in 245 regulatory filings across 14 regulators, without an active US DMF or CEP on file. Its filings concentrate with Health Canada, SFDA (Saudi Arabia) and EDA (EG). Its GMP standing is certified by ZLG (DE), MFDS (Korea) and EMA, among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 30 May 2024 as VAI.

0
active US DMFs
0
valid CEPs
7
registered plants 1 with an FDA FEI number
245
filings across 14 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
7 of 7 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

  • 30 May 2024 VAI US FDA
  • 30 August 2019 NAI US FDA
  • 24 February 2017 VAI US FDA
  • 24 October 2014 NAI US FDA
  • 19 April 2013 NAI US FDA
  • 11 June 2010 NAI US FDA
  • 14 October 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Neustadt, United Arab Emirates Not on file
NEUSTADT AN DER WEINSTRASSE, Germany Not on file
Neustadt Am Rübenberge, Germany Not on file
Hannover, Germany Not on file
Germany, Germany 3002808216
Neustadt, Germany Not on file

1 further sites are on record.

Filings and GMP by regulator

Regulator Filings GMP certificates
Health Canada 136 None
SFDA (Saudi Arabia) 32 None
EDA (EG) 20 None
RAMA (GE) 15 None
DAV (Vietnam) 9 None
EMA 8 2
ZLG (DE) None 14
MFDS (Korea) None 2
ANVISA (Brazil) None 1
US FDA None 1

Questions about Abbott Laboratories

Does Abbott Laboratories hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Abbott Laboratories. It does have 245 filings with 14 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Abbott Laboratories FDA-registered?
One site operated by Abbott Laboratories 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 Laboratories's last inspection go?
The most recent inspection on record closed on 30 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Abbott Laboratories manufacture?
7 registered sites are on record, in United Arab Emirates and Germany (Neustadt, Neustadt AN DER Weinstrasse and Neustadt Am Rübenberge among others). Every site is listed on this page with the register it came from.
Which regulators recognise Abbott Laboratories's GMP?
Current GMP certificates are on record from ZLG (DE), MFDS (Korea), EMA, ANVISA (Brazil) 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.

Comparing suppliers?

Choose your molecules and target markets. Abbott Laboratories comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 30 May 2024.

Comparable suppliers

Aaa Pharmaceuticals also in United States Aarkish Pharmaceuticals NJ also in United States Abon Pharmaceuticals also in United States Access Business Group also in United States Advance Pharmaceutical also in United States

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