Suppliers / Tianjin Tianyao Pharmaceuticals

Tianjin Tianyao Pharmaceuticals

China 600488.SS 35 employees Updated 9 July 2026

Tianjin Tianyao Pharmaceuticals is an API manufacturer based in China. It holds 23 active US drug master files across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 13 December 2024 as VAI.

23
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 December 2024 VAI US FDA
  • 24 May 2019 VAI US FDA
  • 24 August 2017 VAI US FDA
  • 2 September 2016 OAI US FDA
  • 5 July 2013 VAI US FDA
  • 17 June 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
China, China 3008256667

What they file, and where

Molecule Regulators Docs
Methylprednisolone US FDA 4
Betamethasone US FDA 3
Dexamethasone US FDA 3
Prednisolone SFDA (Saudi Arabia), US FDA 3
Prednisone SFDA (Saudi Arabia), US FDA 3
Mometasone Furoate US FDA 2
Budesonide US FDA 1
Celecoxib US FDA 1
Deflazacort US FDA 1
Fluocinonide US FDA 1
Show all 14 molecules on file
Fluticasone Propionate US FDA 1
Hydrocortisone US FDA 1
Spironolactone US FDA 1
Triamcinolone US FDA 1

Also appears on these molecule pages

Show 1 more molecule pages

Filings and GMP by regulator

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

Questions about Tianjin Tianyao Pharmaceuticals

Does Tianjin Tianyao Pharmaceuticals hold a US DMF or a CEP?
Tianjin Tianyao Pharmaceuticals holds 23 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 Tianjin Tianyao Pharmaceuticals FDA-registered?
One site operated by Tianjin Tianyao Pharmaceuticals 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 Tianjin Tianyao Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 13 December 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file, of which 1 closed as OAI.
Where does Tianjin Tianyao Pharmaceuticals 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 Tianjin Tianyao Pharmaceuticals make?
14 molecules are on record against Tianjin Tianyao Pharmaceuticals, including Methylprednisolone, Betamethasone, Dexamethasone and Prednisolone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Tianjin Tianyao Pharmaceuticals'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 13 December 2024.

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Sources on this page

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