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

Heparin API

Filings and GMP by regulator

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

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Open risk flags

  • The most recent inspection outcome was NAI, on 11 December 2025.

Sources on this page

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