Suppliers / Shanxi Shuangyan Pharmaceutical

Shanxi Shuangyan Pharmaceutical

China Updated 9 July 2026

Shanxi Shuangyan Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 4 valid CEPs across a filed portfolio of 4 molecules.

3
active US DMFs
4
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 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
Datong, China Not on file
China, China 3041560253

What they file, and where

Molecule Regulators Docs
Amoxicillin EDQM, US FDA 2
Potassium US FDA 2
Potassium Clavulanate EDQM 2
Amoxicillin Trihydrate EDQM 1

Also appears on these molecule pages

Amoxicillin API Potassium Clavulanate API

Questions about Shanxi Shuangyan Pharmaceutical

Does Shanxi Shuangyan Pharmaceutical hold a US DMF or a CEP?
Shanxi Shuangyan Pharmaceutical holds 3 active US drug master files and 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.
Is Shanxi Shuangyan Pharmaceutical FDA-registered?
One site operated by Shanxi Shuangyan 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 Shanxi Shuangyan Pharmaceutical manufacture?
2 registered sites are on record, in China (Datong and China). Every site is listed on this page with the register it came from.
What does Shanxi Shuangyan Pharmaceutical make?
4 molecules are on record against Shanxi Shuangyan Pharmaceutical, including Amoxicillin, Potassium, Potassium Clavulanate and Amoxicillin Trihydrate. Each links through to that molecule's full manufacturer list.

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

Sinopharm Weiqida Pharmaceutical shares 2 molecules Zhuhai United Laboratories shares 2 molecules Sandoz Industrial Products shares 2 molecules Apitoria Pharma shares 1 molecule Acs Dobfar shares 1 molecule

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