Suppliers / Lotus Pharmaceutical Co Ltd Nantou Plant

Lotus Pharmaceutical Co Ltd Nantou Plant

Taiwan Updated 9 July 2026

Lotus Pharmaceutical Co Ltd Nantou Plant is a finished-dose manufacturer based in Taiwan. It appears in 71 regulatory filings across 7 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by US FDA and EAEU_EEC. Its most recent recorded inspection, by US FDA, closed on 12 April 2024 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
71
filings across 7 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 12 April 2024 VAI US FDA
  • 31 May 2019 NAI US FDA
  • 22 September 2017 VAI US FDA
  • 4 June 2015 VAI US FDA
  • 16 August 2012 NAI US FDA
  • 11 February 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Taiwan, Taiwan 3005999589

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 26 None
ARCSA (EC) 15 None
MINSA (CR) 15 None
INVIMA (CO) 6 None
NCELS (KZ) 4 None
DIGEMAPS (DO) 4 None
US FDA None 1
EAEU_EEC None 1

Questions about Lotus Pharmaceutical Co Ltd Nantou Plant

Does Lotus Pharmaceutical Co Ltd Nantou Plant hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Lotus Pharmaceutical Co Ltd Nantou Plant. It does have 71 filings with 7 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Lotus Pharmaceutical Co Ltd Nantou Plant FDA-registered?
One site operated by Lotus Pharmaceutical Co Ltd Nantou Plant 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 Lotus Pharmaceutical Co Ltd Nantou Plant's last inspection go?
The most recent inspection on record closed on 12 April 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Lotus Pharmaceutical Co Ltd Nantou Plant manufacture?
1 registered site is on record, in Taiwan (Taiwan). Every site is listed on this page with the register it came from.
Which regulators recognise Lotus Pharmaceutical Co Ltd Nantou Plant's GMP?
Current GMP certificates are on record from US FDA and EEC (Eurasian Economic Union). 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 12 April 2024.

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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