Suppliers / Qpharma Ab

Qpharma Ab

Sweden Updated 9 July 2026

Qpharma Ab is a finished-dose manufacturer based in Sweden. It appears in 6 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DIGEMAPS (DO), US FDA and NAFDAC (NG). Its GMP standing is certified by NAFDAC (NG) and US FDA. Its most recent recorded inspection, by US FDA, closed on 6 May 2025 as NAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
6
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 May 2025 NAI US FDA
  • 26 September 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Cedar Knolls, United States 3008626682

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 3 None
US FDA 2 1
NAFDAC (NG) 1 1

Questions about Qpharma Ab

Does Qpharma Ab hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Qpharma Ab. It does have 6 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Qpharma Ab FDA-registered?
One site operated by Qpharma 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 Qpharma Ab's last inspection go?
The most recent inspection on record closed on 6 May 2025 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Qpharma Ab manufacture?
1 registered site is on record, in United States (Cedar Knolls). Every site is listed on this page with the register it came from.
Which regulators recognise Qpharma Ab's GMP?
Current GMP certificates are on record from NAFDAC (NG) 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 NAI, on 6 May 2025.

Comparable suppliers

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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