Suppliers / Mcneil Ab

Mcneil Ab

Sweden Updated 9 July 2026

Mcneil Ab is a finished-dose manufacturer based in Sweden. It appears in 13 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and EDA (EG). Its GMP standing is certified by EMA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 15 June 2022 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
13
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 15 June 2022 VAI US FDA
  • 27 November 2019 VAI US FDA
  • 25 May 2018 VAI US FDA
  • 13 December 2013 NAI US FDA

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

Registered plants

Site FDA FEI
HELSINGBORG, Sweden Not on file
Sweden, Sweden 1000409186

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 7 None
EDA (EG) 6 None
EMA None 3
ANVISA (Brazil) None 1

Questions about Mcneil Ab

Does Mcneil Ab hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Mcneil Ab. It does have 13 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Mcneil Ab FDA-registered?
One site operated by Mcneil Ab 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 Mcneil Ab's last inspection go?
The most recent inspection on record closed on 15 June 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Mcneil Ab manufacture?
2 registered sites are on record, in Sweden (Helsingborg and Sweden). Every site is listed on this page with the register it came from.
Which regulators recognise Mcneil Ab's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). 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 15 June 2022.

Comparable suppliers

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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