Suppliers / Chirogate International

Chirogate International

Taiwan Updated 9 July 2026

Chirogate International is an API manufacturer based in Taiwan. It holds 13 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 29 July 2025 as VAI.

13
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 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

  • 29 July 2025 VAI US FDA
  • 6 December 2018 NAI US FDA
  • 23 May 2014 NAI US FDA
  • 27 October 2010 NAI 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 3006560887

What they file, and where

Molecule Regulators Docs
Travoprost US FDA 2
Treprostinil US FDA 2
Bimatoprost US FDA 1
Carboprost US FDA 1
Dinoprostone US FDA 1
Iloprost US FDA 1
Latanoprost US FDA 1
Latanoprostene Bunod US FDA 1
Tafluprost US FDA 1
Treprostinil Palmitil US FDA 1
Show all 11 molecules on file
Unoprostone US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
US FDA None 1

Questions about Chirogate International

Does Chirogate International hold a US DMF or a CEP?
Chirogate International holds 13 active US drug master files. 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 Chirogate International FDA-registered?
One site operated by Chirogate International 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 Chirogate International's last inspection go?
The most recent inspection on record closed on 29 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Chirogate International manufacture?
1 registered site is on record, in Taiwan (Taiwan). Every site is listed on this page with the register it came from.
What does Chirogate International make?
11 molecules are on record against Chirogate International, including Travoprost, Treprostinil, Bimatoprost and Carboprost. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chirogate International'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 29 July 2025.

Sources on this page

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