Suppliers / Hefei Tianrui Pharmaceutical Chemical

Hefei Tianrui Pharmaceutical Chemical

China Updated 9 July 2026

Hefei Tianrui Pharmaceutical Chemical is an API manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules.

2
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
China, China 3027337495

What they file, and where

Molecule Regulators Docs
Difamilast US FDA 1
Roflumilast US FDA 1

Also appears on these molecule pages

Roflumilast API

Questions about Hefei Tianrui Pharmaceutical Chemical

Does Hefei Tianrui Pharmaceutical Chemical hold a US DMF or a CEP?
Hefei Tianrui Pharmaceutical Chemical holds 2 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 Hefei Tianrui Pharmaceutical Chemical FDA-registered?
One site operated by Hefei Tianrui Pharmaceutical Chemical 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.
Where does Hefei Tianrui Pharmaceutical Chemical 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 Hefei Tianrui Pharmaceutical Chemical make?
2 molecules are on record against Hefei Tianrui Pharmaceutical Chemical, including Difamilast and Roflumilast. Each links through to that molecule's full manufacturer list.

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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability