Suppliers / Zhejiang Xianju Junye Pharmaceutical

Zhejiang Xianju Junye Pharmaceutical

China 22 employees Updated 9 July 2026

Zhejiang Xianju Junye Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 July 2025 as NAI.

2
active US DMFs
3
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 July 2025 NAI US FDA
  • 11 January 2019 NAI US FDA
  • 13 February 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Xianju, China Not on file
China, China 3004072297

What they file, and where

Molecule Regulators Docs
Drospirenone EDQM 1
Estrone US FDA 1
Norethisterone EDQM 1
Prasterone US FDA 1
Tibolone EDQM 1

Also appears on these molecule pages

Drospirenone API Norethisterone API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 11 July 2025.

Sources on this page

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