Suppliers / Henan Dongtai Pharm

Henan Dongtai Pharm

China Updated 9 July 2026

Henan Dongtai Pharm is an API manufacturer based in China. It holds 4 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 August 2023 as NAI.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 August 2023 NAI US FDA
  • 27 July 2018 VAI US FDA
  • 25 September 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
China, China 3008294021

What they file, and where

Molecule Regulators Docs
Diclofenac US FDA 2
Allopurinol US FDA 1
Celecoxib US FDA 1

Also appears on these molecule pages

Allopurinol API Celecoxib API Diclofenac API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
US FDA None 1

Questions about Henan Dongtai Pharm

Does Henan Dongtai Pharm hold a US DMF or a CEP?
Henan Dongtai Pharm holds 4 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 Henan Dongtai Pharm FDA-registered?
One site operated by Henan Dongtai Pharm 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 Henan Dongtai Pharm's last inspection go?
The most recent inspection on record closed on 11 August 2023 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Henan Dongtai Pharm 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 Henan Dongtai Pharm make?
3 molecules are on record against Henan Dongtai Pharm, including Diclofenac, Allopurinol and Celecoxib. Each links through to that molecule's full manufacturer list.
Which regulators recognise Henan Dongtai Pharm'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 NAI, on 11 August 2023.

Comparable suppliers

Hetero shares 3 molecules Ipca Laboratories shares 2 molecules Macleods Pharmaceuticals shares 2 molecules Amoli Organics shares 2 molecules Apitoria Pharma shares 1 molecule

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