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

Questions about Nanogen

Does Nanogen hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Nanogen. It does have 33 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Nanogen FDA-registered?
One site operated by Nanogen 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 Nanogen's last inspection go?
The most recent inspection on record closed on 21 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Nanogen manufacture?
1 registered site is on record, in South Korea (South). Every site is listed on this page with the register it came from.
What does Nanogen make?
5 molecules are on record against Nanogen, including Docetaxel, Oxaliplatin, Paclitaxel and Leucovorin Calcium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nanogen'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.

Checking Nanogen?

Ask Fred what the record holds on Nanogen, including filings and inspection history.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Open risk flags

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

Comparable suppliers

Hetero shares 2 molecules Laurus Labs shares 2 molecules Shilpa Pharma Lifesciences shares 2 molecules MSN Laboratories shares 1 molecule Cipla shares 1 molecule

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