Suppliers / Zhejiang Shenzhou Pharmaceutical

Zhejiang Shenzhou Pharmaceutical

China 2 employees Updated 9 July 2026

Zhejiang Shenzhou Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as VAI.

5
active US DMFs
0
valid CEPs
1
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

  • 12 September 2025 VAI US FDA
  • 8 June 2018 NAI US FDA
  • 18 October 2013 NAI US FDA
  • 8 September 2011 NAI US FDA

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

Registered plants

Site FDA FEI
China, China 3005463252

What they file, and where

Molecule Regulators Docs
Progesterone SFDA (Saudi Arabia), US FDA 3
Abiraterone US FDA 1
Eplerenone US FDA 1
Spironolactone US FDA 1

Also appears on these molecule pages

Abiraterone API Eplerenone API Progesterone API Spironolactone API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Shenzhou Pharmaceutical

Does Zhejiang Shenzhou Pharmaceutical hold a US DMF or a CEP?
Zhejiang Shenzhou Pharmaceutical holds 5 active US drug master files. 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 Shenzhou Pharmaceutical FDA-registered?
One site operated by Zhejiang Shenzhou 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 Shenzhou Pharmaceutical's last inspection go?
The most recent inspection on record closed on 12 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Zhejiang Shenzhou Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Zhejiang Shenzhou Pharmaceutical make?
4 molecules are on record against Zhejiang Shenzhou Pharmaceutical, including Progesterone, Abiraterone, Eplerenone and Spironolactone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Shenzhou 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 VAI, on 12 September 2025.

Comparable suppliers

Industriale Chimica shares 3 molecules MSN Laboratories shares 2 molecules Hetero shares 2 molecules Aurisco Pharmaceutical Co.,Ltd shares 2 molecules Apitoria Pharma shares 1 molecule

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