Suppliers / Sinopharm Weiqida Pharmaceutical

Sinopharm Weiqida Pharmaceutical

China Updated 9 July 2026

Sinopharm Weiqida Pharmaceutical is an API manufacturer based in China. It holds 9 active US drug master files and 7 valid CEPs across a filed portfolio of 8 molecules. Its filings concentrate with PPB (KE), NAFDAC (NG) and ARCSA (EC). Its GMP standing is certified by US FDA and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 25 May 2023 as VAI.

9
active US DMFs
7
valid CEPs
2
registered plants 1 with an FDA FEI number
15
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 May 2023 VAI US FDA
  • 21 July 2017 NAI US FDA
  • 1 May 2015 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Datong, China Not on file
China, China 3010166430

What they file, and where

Molecule Regulators Docs
Amoxicillin EDQM, US FDA 4
Potassium Clavulanate EDQM, SFDA (Saudi Arabia) 4
Clavulanic Acid US FDA 3
Ampicillin EDQM, US FDA 2
Amoxicillin Trihydrate EDQM 1
Ceftriaxone US FDA 1
Cefuroxime US FDA 1
Lipoic Acid EDQM 1

Also appears on these molecule pages

Amoxicillin API Ampicillin API Ceftriaxone API Cefuroxime API Clavulanic Acid API Lipoic Acid API Potassium Clavulanate API

Filings and GMP by regulator

Regulator Filings GMP certificates
PPB (KE) 6 None
NAFDAC (NG) 5 1
ARCSA (EC) 2 None
DAV (Vietnam) 1 None
CDSCO (India) 1 None
US FDA None 1

Questions about Sinopharm Weiqida Pharmaceutical

Does Sinopharm Weiqida Pharmaceutical hold a US DMF or a CEP?
Sinopharm Weiqida Pharmaceutical holds 9 active US drug master files and 7 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 Sinopharm Weiqida Pharmaceutical FDA-registered?
One site operated by Sinopharm Weiqida 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.
How did Sinopharm Weiqida Pharmaceutical's last inspection go?
The most recent inspection on record closed on 25 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Sinopharm Weiqida 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 Sinopharm Weiqida Pharmaceutical make?
8 molecules are on record against Sinopharm Weiqida Pharmaceutical, including Amoxicillin, Potassium Clavulanate, Clavulanic Acid and Ampicillin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sinopharm Weiqida Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA and NAFDAC (NG). 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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Open risk flags

  • The most recent inspection outcome was VAI, on 25 May 2023.

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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