Suppliers / Dongying Tiandong Pharmaceutical

Dongying Tiandong Pharmaceutical

China Updated 9 July 2026

Dongying Tiandong Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with ARCSA (EC) and NCELS (KZ). Its GMP standing is certified by EMA and NCELS (KZ). Its most recent recorded inspection, by US FDA, closed on 19 October 2018 as VAI.

2
active US DMFs
1
valid CEPs
3
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 19 October 2018 VAI US FDA
  • 16 October 2015 OAI US FDA
  • 2 August 2013 NAI US FDA

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

Registered plants

Site FDA FEI
DONGYING, China Not on file
Dongying City, China Not on file
China, China 3004395180

What they file, and where

Molecule Regulators Docs
Enoxaparin EDQM, US FDA 2
Heparin Sodium US FDA 1

Also appears on these molecule pages

Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 4 None
NCELS (KZ) 1 1
EMA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 19 October 2018.

Sources on this page

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