Suppliers / Taiwan Biotech

Taiwan Biotech

Taiwan 36 employees Updated 9 July 2026

Taiwan Biotech is an API manufacturer based in Taiwan. It holds one active US drug master file and one valid CEP. Its filings concentrate with DAV (Vietnam), NPRA (MY) and MINSA (CR). Its most recent recorded inspection, by US FDA, closed on 20 September 2022 as OAI.

1
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
34
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 20 September 2022 OAI US FDA
  • 11 September 2017 OAI US FDA
  • 30 May 2014 VAI US FDA
  • 26 August 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Taoyuan City, Taiwan Not on file
Taiwan, Taiwan 3003598505

What they file, and where

Molecule Regulators Docs
Bisoprolol EDQM, US FDA 2

Also appears on these molecule pages

Bisoprolol API

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 19 None
NPRA (MY) 10 None
MINSA (CR) 3 None
NMPA (CN) 2 None

Questions about Taiwan Biotech

Does Taiwan Biotech hold a US DMF or a CEP?
Taiwan Biotech holds 1 active US drug master file and 1 valid CEP. 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 Taiwan Biotech FDA-registered?
One site operated by Taiwan Biotech 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 Taiwan Biotech's last inspection go?
The most recent inspection on record closed on 20 September 2022 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 4 inspections are on file, of which 2 closed as OAI.
Where does Taiwan Biotech manufacture?
2 registered sites are on record, in Taiwan (Taoyuan City and Taiwan). Every site is listed on this page with the register it came from.
What does Taiwan Biotech make?
1 molecule is on record against Taiwan Biotech, including Bisoprolol. Each links through to that molecule's full manufacturer list.
Where does Taiwan Biotech file?
Filings are on record with DAV (Vietnam), NPRA (MY), MINSA (CR) and NMPA (CN), 34 in total.

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 OAI, on 20 September 2022.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability