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 Prasterone API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Xianju Junye Pharmaceutical

Does Zhejiang Xianju Junye Pharmaceutical hold a US DMF or a CEP?
Zhejiang Xianju Junye Pharmaceutical holds 2 active US drug master files and 3 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 Zhejiang Xianju Junye Pharmaceutical FDA-registered?
One site operated by Zhejiang Xianju Junye 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 Zhejiang Xianju Junye Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 July 2025 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Zhejiang Xianju Junye Pharmaceutical manufacture?
2 registered sites are on record, in China (Xianju and China). Every site is listed on this page with the register it came from.
What does Zhejiang Xianju Junye Pharmaceutical make?
5 molecules are on record against Zhejiang Xianju Junye Pharmaceutical, including Drospirenone, Estrone, Norethisterone and Prasterone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Xianju Junye Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA. 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 NAI, on 11 July 2025.

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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
EudraGMDP and national regulators
GMP certificates