Suppliers / Zhongshan Belling Biotechnology

Zhongshan Belling Biotechnology

China Updated 9 July 2026

Zhongshan Belling Biotechnology is an API manufacturer based in China. It holds one active US drug master file and 2 valid CEPs. Its GMP standing is certified by MFDS (Korea).

1
active US DMFs
2
valid CEPs
2
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Zhongshan City, China Not on file
China, China 3014353739

What they file, and where

Molecule Regulators Docs
Ursodeoxycholic Acid EDQM, US FDA 3

Also appears on these molecule pages

Ursodeoxycholic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Zhongshan Belling Biotechnology

Does Zhongshan Belling Biotechnology hold a US DMF or a CEP?
Zhongshan Belling Biotechnology holds 1 active US drug master file and 2 valid CEPs. 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 Zhongshan Belling Biotechnology FDA-registered?
One site operated by Zhongshan Belling 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.
Where does Zhongshan Belling Biotechnology manufacture?
2 registered sites are on record, in China (Zhongshan City and China). Every site is listed on this page with the register it came from.
What does Zhongshan Belling Biotechnology make?
1 molecule is on record against Zhongshan Belling Biotechnology, including Ursodeoxycholic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhongshan Belling Biotechnology's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Sources on this page

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