Suppliers / Jiangsu Grand Xianle Pharmaceutical

Jiangsu Grand Xianle Pharmaceutical

China Updated 9 July 2026

Jiangsu Grand Xianle Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file and 5 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by EMA.

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

What they file, and where

Molecule Regulators Docs
Betamethasone EDQM 1
Clobetasol Propionate EDQM 1
Cyproterone EDQM 1
Medroxyprogesterone Acetate EDQM 1
Megestrol Acetate US FDA 1
Prednisolone EDQM 1

Also appears on these molecule pages

Betamethasone API Clobetasol API Cyproterone API Medroxyprogesterone API Megestrol API Prednisolone API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2

Questions about Jiangsu Grand Xianle Pharmaceutical

Does Jiangsu Grand Xianle Pharmaceutical hold a US DMF or a CEP?
Jiangsu Grand Xianle Pharmaceutical holds 1 active US drug master file and 5 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.
Where does Jiangsu Grand Xianle Pharmaceutical manufacture?
2 registered sites are on record, in China (Yancheng and Yancheng City). Every site is listed on this page with the register it came from.
What does Jiangsu Grand Xianle Pharmaceutical make?
6 molecules are on record against Jiangsu Grand Xianle Pharmaceutical, including Betamethasone, Clobetasol Propionate, Cyproterone and Medroxyprogesterone Acetate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jiangsu Grand Xianle 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