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

Azilsartan Medoxomil API Febuxostat API Montelukast API Vildagliptin API Valsartan API Dapagliflozin API Sacubitril API Ticagrelor API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Linhai Tianyu Pharmaceutical

Does Linhai Tianyu Pharmaceutical hold a US DMF or a CEP?
Linhai Tianyu Pharmaceutical holds 11 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 Linhai Tianyu Pharmaceutical FDA-registered?
One site operated by Linhai Tianyu Pharmaceutical 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 Linhai Tianyu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 15 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file, of which 1 closed as OAI.
Where does Linhai Tianyu Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Linhai Tianyu Pharmaceutical make?
9 molecules are on record against Linhai Tianyu Pharmaceutical, including Azilsartan Medoxomil, Valsartan, Apixaban and Dapagliflozin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Linhai Tianyu Pharmaceutical'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 15 September 2023.

Comparable suppliers

Apitoria Pharma shares 3 molecules Alembic Pharmaceuticals shares 3 molecules Jubilant Biosys shares 3 molecules Jiangxi Synergy Pharmaceutical shares 3 molecules Dr Reddy's Laboratories shares 2 molecules

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