Suppliers / Sichuan Xieli Pharmaceutical

Sichuan Xieli Pharmaceutical

China 12 employees Updated 9 July 2026

Sichuan Xieli Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files and 5 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 26 September 2025 as NAI.

11
active US DMFs
5
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
Inspections
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 26 September 2025 NAI US FDA
  • 27 September 2018 NAI US FDA
  • 1 July 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Pengzhou, China Not on file
China, China 3007432586

What they file, and where

Molecule Regulators Docs
Diosmin EDQM, SFDA (Saudi Arabia), US FDA 4
Irinotecan EDQM, SFDA (Saudi Arabia), US FDA 3
Cytisine US FDA 2
Troxerutin EDQM, US FDA 2
Anastrozole EDQM 1
Berberine US FDA 1
Cabazitaxel US FDA 1
Erlotinib US FDA 1
Gefitinib US FDA 1
Hesperidin SFDA (Saudi Arabia) 1
Show all 12 molecules on file
Ingenol Mebutate US FDA 1
Ursodeoxycholic Acid US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 26 September 2025.

Sources on this page

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