Suppliers / Bloomage Biotechnology

Bloomage Biotechnology

China Updated 9 July 2026

Bloomage Biotechnology is an API manufacturer based in China. It holds 12 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with EDE (AE) and MINSA (CR). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 28 March 2025 as NAI.

12
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
4
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 March 2025 NAI US FDA
  • 26 April 2019 VAI US FDA
  • 14 November 2014 VAI US FDA
  • 1 March 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Jinan, United Arab Emirates Not on file
China, China 3008240723

What they file, and where

Molecule Regulators Docs
Hyaluronic Acid US FDA 11
Ectoine US FDA 1

Also appears on these molecule pages

Hyaluronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
EDE (AE) 3 None
MINSA (CR) 1 None
MFDS (Korea) None 2
US FDA None 1

Questions about Bloomage Biotechnology

Does Bloomage Biotechnology hold a US DMF or a CEP?
Bloomage Biotechnology holds 12 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 Bloomage Biotechnology FDA-registered?
One site operated by Bloomage Biotechnology 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 Bloomage Biotechnology's last inspection go?
The most recent inspection on record closed on 28 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Bloomage Biotechnology manufacture?
2 registered sites are on record, in United Arab Emirates and China (Jinan and China). Every site is listed on this page with the register it came from.
What does Bloomage Biotechnology make?
2 molecules are on record against Bloomage Biotechnology, including Hyaluronic Acid and Ectoine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Bloomage Biotechnology'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 28 March 2025.

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Sources on this page

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