Suppliers / Shaanxi Hanjiang Pharmaceutical Group

Shaanxi Hanjiang Pharmaceutical Group

China 18 employees Updated 9 July 2026

Shaanxi Hanjiang Pharmaceutical Group is an API manufacturer based in China. It holds one active US drug master file and 9 valid CEPs across a filed portfolio of 7 molecules. Its most recent recorded inspection, by US FDA, closed on 15 July 2016 as VAI.

1
active US DMFs
9
valid CEPs
4
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 July 2016 VAI US FDA
  • 13 December 2013 VAI US FDA
  • 14 October 2010 NAI US FDA
  • 21 November 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Hanzhong, China Not on file
Hanzhong City, China Not on file
Hanzhong City, China Not on file
China, China 3003011617

What they file, and where

Molecule Regulators Docs
Progesterone EDQM, SFDA (Saudi Arabia) 3
Estradiol EDQM 2
Mebendazole EDQM, US FDA 2
Racecadotril EDQM, SFDA (Saudi Arabia) 2
Fenbendazole For Veterinary Use EDQM 1
Flubendazole EDQM 1
Oxfendazole For Veterinary Use EDQM 1

Also appears on these molecule pages

Questions about Shaanxi Hanjiang Pharmaceutical Group

Does Shaanxi Hanjiang Pharmaceutical Group hold a US DMF or a CEP?
Shaanxi Hanjiang Pharmaceutical Group holds 1 active US drug master file and 9 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 Shaanxi Hanjiang Pharmaceutical Group FDA-registered?
One site operated by Shaanxi Hanjiang Pharmaceutical Group 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 Shaanxi Hanjiang Pharmaceutical Group's last inspection go?
The most recent inspection on record closed on 15 July 2016 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Shaanxi Hanjiang Pharmaceutical Group manufacture?
4 registered sites are on record, in China (Hanzhong, Hanzhong City and China among others). Every site is listed on this page with the register it came from.
What does Shaanxi Hanjiang Pharmaceutical Group make?
7 molecules are on record against Shaanxi Hanjiang Pharmaceutical Group, including Progesterone, Estradiol, Mebendazole and Racecadotril. 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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Open risk flags

  • The most recent inspection outcome was VAI, on 15 July 2016.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability