Suppliers / North China Pharmaceutical Group Semisyntech

North China Pharmaceutical Group Semisyntech

China Updated 9 July 2026

The public registers hold a second record for North China Pharmaceutical Group Semisyntech. The fuller profile, with 9 active US DMFs and 5 valid CEPs, is at North China Pharmaceutical. Figures on this page cover only this record.

North China Pharmaceutical Group Semisyntech is an API manufacturer based in China. It holds 4 valid CEPs across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA and MHRA (UK).

0
active US DMFs
4
valid CEPs
3
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
Shijiazhuang, China Not on file
SHIJIAZHUANG, China Not on file
Shijiazhuang, China Not on file

What they file, and where

Molecule Regulators Docs
Amoxicillin Trihydrate EDQM 2
Amoxicillin EDQM 1
Ampicillin Trihydrate EDQM 1

Also appears on these molecule pages

Amoxicillin API Ampicillin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2
MHRA (UK) None 1

Questions about North China Pharmaceutical Group Semisyntech

Does North China Pharmaceutical Group Semisyntech hold a US DMF or a CEP?
North China Pharmaceutical Group Semisyntech holds 4 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 North China Pharmaceutical Group Semisyntech manufacture?
3 registered sites are on record, in China (Shijiazhuang and Shijiazhuang among others). Every site is listed on this page with the register it came from.
What does North China Pharmaceutical Group Semisyntech make?
3 molecules are on record against North China Pharmaceutical Group Semisyntech, including Amoxicillin Trihydrate, Amoxicillin and Ampicillin Trihydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise North China Pharmaceutical Group Semisyntech's GMP?
Current GMP certificates are on record from EMA and MHRA (UK). 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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Comparable suppliers

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates