Suppliers / Linhai Tianyu Pharmaceutical

Linhai Tianyu Pharmaceutical

China Updated 9 July 2026

Linhai Tianyu Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 15 September 2023 as VAI.

11
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 September 2023 VAI US FDA
  • 19 April 2019 OAI US FDA

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

Registered plants

Site FDA FEI
China, China 3013345425

What they file, and where

Molecule Regulators Docs
Azilsartan Medoxomil US FDA 2
Valsartan US FDA 2
Apixaban US FDA 1
Dapagliflozin US FDA 1
Febuxostat US FDA 1
Montelukast US FDA 1
Sacubitril US FDA 1
Ticagrelor US FDA 1
Vildagliptin US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 15 September 2023.

Sources on this page

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