Suppliers / New Zealand Pharmaceuticals

New Zealand Pharmaceuticals

New Zealand 64 employees 2 duplicate records merged Updated 9 July 2026

New Zealand Pharmaceuticals is an API manufacturer based in New Zealand. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 16 May 2025 as VAI.

1
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
192
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 16 May 2025 VAI US FDA
  • 25 May 2018 VAI US FDA
  • 16 May 2014 VAI US FDA

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

Registered plants

Site FDA FEI
New Zealand, New Zealand 3003430615

What they file, and where

Molecule Regulators Docs
Cholic Acid US FDA 1

Also appears on these molecule pages

Cholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MEDSAFE (NZ) 192 None
US FDA None 1

Questions about New Zealand Pharmaceuticals

Does New Zealand Pharmaceuticals hold a US DMF or a CEP?
New Zealand Pharmaceuticals holds 1 active US drug master file. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is New Zealand Pharmaceuticals FDA-registered?
One site operated by New Zealand Pharmaceuticals 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 New Zealand Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 16 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does New Zealand Pharmaceuticals manufacture?
1 registered site is on record, in New Zealand (New Zealand). Every site is listed on this page with the register it came from.
What does New Zealand Pharmaceuticals make?
1 molecule is on record against New Zealand Pharmaceuticals, including Cholic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise New Zealand Pharmaceuticals's GMP?
Current GMP certificates are on record from 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 16 May 2025.

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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