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

Enoxaparin API Heparin API

Filings and GMP by regulator

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

Questions about Dongying Tiandong Pharmaceutical

Does Dongying Tiandong Pharmaceutical hold a US DMF or a CEP?
Dongying Tiandong Pharmaceutical holds 2 active US drug master files and 1 valid CEP. 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 Dongying Tiandong Pharmaceutical FDA-registered?
One site operated by Dongying Tiandong 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 Dongying Tiandong Pharmaceutical's last inspection go?
The most recent inspection on record closed on 19 October 2018 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file, of which 1 closed as OAI.
Where does Dongying Tiandong Pharmaceutical manufacture?
3 registered sites are on record, in China (Dongying, Dongying City and China). Every site is listed on this page with the register it came from.
What does Dongying Tiandong Pharmaceutical make?
2 molecules are on record against Dongying Tiandong Pharmaceutical, including Enoxaparin and Heparin Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dongying Tiandong Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and NCELS (KZ). 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.

Checking Dongying Tiandong Pharmaceutical?

Ask Fred what the record holds on Dongying Tiandong Pharmaceutical, including filings and inspection history.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Open risk flags

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

Comparable suppliers

Gland Pharma shares 2 molecules Hebei Changshan Biochemical Pharmaceutical shares 2 molecules Hubei Enoray Biopharmaceutical shares 2 molecules Nanjing King-Friend Biochemical Pharmaceutical shares 2 molecules Yantai Dongcheng Biochemicals Co.,Ltd shares 2 molecules

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