Suppliers / Nanogen

Nanogen

Vietnam Updated 9 July 2026

Nanogen is an API and finished-dose manufacturer based in Vietnam. It appears in 33 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 21 February 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
33
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 21 February 2025 VAI US FDA

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

Registered plants

Site FDA FEI
South, South Korea 3014653467

What they file, and where

Molecule Regulators Docs
Docetaxel DAV (Vietnam) 3
Oxaliplatin DAV (Vietnam) 2
Paclitaxel DAV (Vietnam) 2
Leucovorin Calcium DAV (Vietnam) 1
Pemetrexed DAV (Vietnam) 1

Also appears on these molecule pages

Epirubicin finished dose Leucovorin API Oxaliplatin API Pemetrexed API Paclitaxel API Docetaxel API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 33 None
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 21 February 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates