Suppliers / Hp Halden Pharma

Hp Halden Pharma

Norway 16 employees Updated 9 July 2026

Hp Halden Pharma is a finished-dose manufacturer based in Norway. It appears in 21 regulatory filings across 6 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), EDE (AE) and DIGEMAPS (DO). Its GMP standing is certified by ANVISA (Brazil), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 10 May 2023 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
21
filings across 6 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

  • 10 May 2023 VAI US FDA
  • 3 September 2019 VAI US FDA
  • 26 May 2017 VAI US FDA
  • 26 June 2015 VAI US FDA
  • 20 December 2013 VAI US FDA
  • 23 August 2012 VAI US FDA
  • 17 November 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
Halden, United Arab Emirates Not on file
HALDEN, Norway Not on file
Norway, Norway 3002608066

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 6 None
EDE (AE) 5 None
DIGEMAPS (DO) 3 None
US FDA 3 1
MINSA (CR) 3 None
INVIMA (CO) 1 None
ANVISA (Brazil) None 2
EMA None 1

Scale

Year Revenue Exports Destinations
2024 $117.4M Not reported Not reported

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

Questions about Hp Halden Pharma

Does Hp Halden Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hp Halden Pharma. It does have 21 filings with 6 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Hp Halden Pharma FDA-registered?
One site operated by Hp Halden Pharma 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 Hp Halden Pharma's last inspection go?
The most recent inspection on record closed on 10 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Hp Halden Pharma manufacture?
3 registered sites are on record, in United Arab Emirates and Norway (Halden, Halden and Norway). Every site is listed on this page with the register it came from.
Which regulators recognise Hp Halden Pharma's GMP?
Current GMP certificates are on record from ANVISA (Brazil), EMA 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 10 May 2023.

Comparable suppliers

Epax Norway also in Norway Palla Pharma Norway also in Norway Vistin Pharma also in Norway GE Healthcare also in Norway

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
Company filings
Revenue as reported