Suppliers / Beijing Beilu Pharmaceutical

Beijing Beilu Pharmaceutical

China 74 employees Updated 9 July 2026

Beijing Beilu Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with DIGEMAPS (DO), EFDA (ET) and MINSA (CR). Its GMP standing is certified by EMA and ANVISA (Brazil).

2
active US DMFs
0
valid CEPs
2
registered plants
23
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
BEIJING (PEQUIM), China Not on file
Beijing, China Not on file

What they file, and where

Molecule Regulators Docs
Gadobutrol US FDA 1
Gadoteric Acid US FDA 1

Also appears on these molecule pages

Gadobutrol API Gadoteric Acid API Iohexol finished dose Iopamidol finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 8 None
EFDA (ET) 5 None
MINSA (CR) 4 None
ARCSA (EC) 4 None
BOMRA (BW) 2 None
EMA None 1
ANVISA (Brazil) None 1

Questions about Beijing Beilu Pharmaceutical

Does Beijing Beilu Pharmaceutical hold a US DMF or a CEP?
Beijing Beilu Pharmaceutical 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.
Where does Beijing Beilu Pharmaceutical manufacture?
2 registered sites are on record, in China (Beijing (pequim) and Beijing). Every site is listed on this page with the register it came from.
What does Beijing Beilu Pharmaceutical make?
2 molecules are on record against Beijing Beilu Pharmaceutical, including Gadobutrol and Gadoteric Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Beijing Beilu Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and ANVISA (Brazil). 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