Suppliers / Zhejiang Tianyu Pharmaceutical

Zhejiang Tianyu Pharmaceutical

China 133 employees Updated 9 July 2026

Zhejiang Tianyu Pharmaceutical is an API manufacturer based in China. It holds 12 active US drug master files and 17 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 29 November 2024 as VAI.

12
active US DMFs
17
valid CEPs
3
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
4 of 4 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

  • 29 November 2024 VAI US FDA
  • 4 March 2022 OAI US FDA
  • 12 April 2019 OAI US FDA
  • 12 June 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Taizhou City, China Not on file
Taizhou, China Not on file
China, China 3010972581

What they file, and where

Molecule Regulators Docs
Losartan EDQM, SFDA (Saudi Arabia), US FDA 4
Valsartan EDQM, US FDA 4
Irbesartan EDQM, SFDA (Saudi Arabia) 3
Montelukast EDQM, US FDA 2
Olmesartan Medoxomil EDQM, SFDA (Saudi Arabia) 2
Rivaroxaban EDQM, US FDA 2
Sacubitril US FDA 2
Telmisartan EDQM 2
Brivaracetam EDQM 1
Cabozantinib US FDA 1
Show all 19 molecules on file
Candesartan Cilexetil EDQM 1
Dabigatran Etexilate Mesilate EDQM 1
Edoxaban US FDA 1
Ezetimibe US FDA 1
Losartan Potassium EDQM 1
Nicorandil EDQM 1
Olmesartan US FDA 1
Sitagliptin EDQM 1
Ticagrelor EDQM 1

Also appears on these molecule pages

Brivaracetam API Cabozantinib API Candesartan Cilexetil API Dabigatran Etexilate Mesilate API Edoxaban API Ezetimibe API Irbesartan API Losartan API Montelukast API Olmesartan API Olmesartan Medoxomil API Sacubitril API
Show 5 more molecule pages
Valsartan API Sitagliptin API Telmisartan API Rivaroxaban API Ticagrelor API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Zhejiang Tianyu Pharmaceutical

Does Zhejiang Tianyu Pharmaceutical hold a US DMF or a CEP?
Zhejiang Tianyu Pharmaceutical holds 12 active US drug master files and 17 valid CEPs. 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 Zhejiang Tianyu Pharmaceutical FDA-registered?
One site operated by Zhejiang 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 Zhejiang Tianyu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 29 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file, of which 2 closed as OAI.
Where does Zhejiang Tianyu Pharmaceutical manufacture?
3 registered sites are on record, in China (Taizhou City, Taizhou and China). Every site is listed on this page with the register it came from.
What does Zhejiang Tianyu Pharmaceutical make?
19 molecules are on record against Zhejiang Tianyu Pharmaceutical, including Losartan, Valsartan, Irbesartan and Montelukast. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Tianyu Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and 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 November 2024.

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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