Suppliers / Yantai Dongcheng Biochemicals Co.,Ltd

Yantai Dongcheng Biochemicals Co.,Ltd

China Updated 9 July 2026

Yantai Dongcheng Biochemicals Co.,Ltd is an API manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 11 December 2025 as NAI.

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

Inspection history

  • 11 December 2025 NAI US FDA
  • 9 June 2023 NAI US FDA
  • 17 January 2020 NAI US FDA
  • 19 January 2018 NAI US FDA
  • 17 April 2015 VAI US FDA
  • 5 February 2009 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 3004248487

What they file, and where

Molecule Regulators Docs
Enoxaparin US FDA 1
Heparin Sodium US FDA 1

Also appears on these molecule pages

Enoxaparin API Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Yantai Dongcheng Biochemicals Co.,Ltd

Does Yantai Dongcheng Biochemicals Co.,Ltd hold a US DMF or a CEP?
Yantai Dongcheng Biochemicals Co.,Ltd 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 Yantai Dongcheng Biochemicals Co.,Ltd FDA-registered?
One site operated by Yantai Dongcheng Biochemicals Co.,Ltd 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 Yantai Dongcheng Biochemicals Co.,Ltd's last inspection go?
The most recent inspection on record closed on 11 December 2025 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Yantai Dongcheng Biochemicals Co.,Ltd 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 Yantai Dongcheng Biochemicals Co.,Ltd make?
2 molecules are on record against Yantai Dongcheng Biochemicals Co.,Ltd, including Enoxaparin and Heparin Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Yantai Dongcheng Biochemicals Co.,Ltd's GMP?
Current GMP certificates are on record from MFDS (Korea) and 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 December 2025.

Comparable suppliers

Gland Pharma shares 2 molecules Dongying Tiandong Pharmaceutical shares 2 molecules Hebei Changshan Biochemical Pharmaceutical shares 2 molecules Hubei Enoray Biopharmaceutical shares 2 molecules Nanjing King-Friend Biochemical Pharmaceutical 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