Suppliers / Brightgene Pharmaceutical

Brightgene Pharmaceutical

China 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Brightgene Pharmaceutical. The fuller profile, with 41 active US DMFs and 3 valid CEPs, is at BrightGene Bio-Medical. Figures on this page cover only this record.

Brightgene Pharmaceutical is an API and finished-dose manufacturer based in China. It appears in 5 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with MINSA (CR) and US FDA. Its GMP standing is certified by EMA.

0
active US DMFs
0
valid CEPs
1
registered plants
5
filings across 2 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
Suzhou, China Not on file

What they file, and where

Molecule Regulators Docs
Caspofungin SFDA (Saudi Arabia) 2
Anidulafungin SFDA (Saudi Arabia) 1
Entecavir SFDA (Saudi Arabia) 1
Micafungin SFDA (Saudi Arabia) 1
Sugammadex SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Caspofungin API Entecavir API Fondaparinux finished dose Micafungin API Sugammadex API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
US FDA 1 None
EMA None 2

Questions about Brightgene Pharmaceutical

Does Brightgene Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Brightgene Pharmaceutical. It does have 5 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Brightgene Pharmaceutical manufacture?
1 registered site is on record, in China (Suzhou). Every site is listed on this page with the register it came from.
What does Brightgene Pharmaceutical make?
5 molecules are on record against Brightgene Pharmaceutical, including Caspofungin, Anidulafungin, Entecavir and Micafungin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Brightgene Pharmaceutical's GMP?
Current GMP certificates are on record from EMA. 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