Suppliers / CSPC Zhongnuo Pharmaceutical (Shijiazhuang)

CSPC Zhongnuo Pharmaceutical (Shijiazhuang)

China Updated 9 July 2026

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) is a finished-dose manufacturer based in China. It holds one active US drug master file. Its filings concentrate with NAFDAC (NG), ARCSA (EC) and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and INVIMA (CO).

1
active US DMFs
0
valid CEPs
5
registered plants 2 with an FDA FEI number
60
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Shijiazhuang, China Not on file
Shijiazhuang City, China Not on file
China, China 3010166013
China, China 3003196232
Shijiazhuang, Colombia Not on file

What they file, and where

Molecule Regulators Docs
Procaine Benzylpenicillin US FDA 1

Also appears on these molecule pages

Benzylpenicillin finished dose Cloxacillin finished dose Tazobactam finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
NAFDAC (NG) 21 None
ARCSA (EC) 14 None
MINSA (CR) 10 None
EFDA (ET) 6 None
ZAMRA (ZM) 2 None
INVIMA (CO) 2 1
EMA None 2
MFDS (Korea) None 2

Questions about CSPC Zhongnuo Pharmaceutical (Shijiazhuang)

Does CSPC Zhongnuo Pharmaceutical (Shijiazhuang) hold a US DMF or a CEP?
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) holds 1 active US drug master file. 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 CSPC Zhongnuo Pharmaceutical (Shijiazhuang) FDA-registered?
2 sites operated by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
Where does CSPC Zhongnuo Pharmaceutical (Shijiazhuang) manufacture?
5 registered sites are on record, in China and Colombia (Shijiazhuang, Shijiazhuang City and China among others). Every site is listed on this page with the register it came from.
What does CSPC Zhongnuo Pharmaceutical (Shijiazhuang) make?
1 molecule is on record against CSPC Zhongnuo Pharmaceutical (Shijiazhuang), including Procaine Benzylpenicillin. Each links through to that molecule's full manufacturer list.
Which regulators recognise CSPC Zhongnuo Pharmaceutical (Shijiazhuang)'s GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and INVIMA (CO). 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