Suppliers / Sichuan Kelun Pharmaceutical

Sichuan Kelun Pharmaceutical

China 12 employees Updated 9 July 2026

Sichuan Kelun Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 17 active US drug master files across a filed portfolio of 17 molecules. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and NAFDAC (NG). Its GMP standing is certified by NAFDAC (NG), UZPHARM (UZ) and ANVISA (Brazil), among 4 authorities.

17
active US DMFs
0
valid CEPs
5
registered plants 1 with an FDA FEI number
33
filings across 3 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
Qionglai, China Not on file
SICHUAN, China Not on file
China, China 3026331762
Hunan Province, Nigeria Not on file
P.R. CHINA, Nigeria Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 16 None
UZPHARM (UZ) 11 1
NAFDAC (NG) 6 2
ANVISA (Brazil) None 1
NCELS (KZ) None 1

Questions about Sichuan Kelun Pharmaceutical

Does Sichuan Kelun Pharmaceutical hold a US DMF or a CEP?
Sichuan Kelun Pharmaceutical holds 17 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 Sichuan Kelun Pharmaceutical FDA-registered?
One site operated by Sichuan Kelun Pharmaceutical 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 Sichuan Kelun Pharmaceutical manufacture?
5 registered sites are on record, in China and Nigeria (Qionglai, Sichuan and China among others). Every site is listed on this page with the register it came from.
What does Sichuan Kelun Pharmaceutical make?
17 molecules are on record against Sichuan Kelun Pharmaceutical, including Apalutamide, Aprepitant, Empagliflozin and Enzalutamide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sichuan Kelun Pharmaceutical's GMP?
Current GMP certificates are on record from NAFDAC (NG), UZPHARM (UZ), ANVISA (Brazil) and NCELS (KZ). 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