Suppliers / Zhejiang Haisen Pharmaceutical

Zhejiang Haisen Pharmaceutical

China 5 employees Updated 9 July 2026

Zhejiang Haisen Pharmaceutical is an API manufacturer based in China. It holds 4 active US drug master files and 4 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 15 November 2024 as VAI.

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

Inspection history

  • 15 November 2024 VAI US FDA
  • 12 December 2014 NAI US FDA

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

Registered plants

Site FDA FEI
Xiangtan Village, China Not on file
China, China 3003967524

What they file, and where

Molecule Regulators Docs
Atorvastatin EDQM, US FDA 3
Sucralfate EDQM, US FDA 2
Escitalopram US FDA 1
Metamizole EDQM 1
Paroxetine US FDA 1

Also appears on these molecule pages

Atorvastatin API Paroxetine API Sucralfate API Escitalopram API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Haisen Pharmaceutical

Does Zhejiang Haisen Pharmaceutical hold a US DMF or a CEP?
Zhejiang Haisen Pharmaceutical holds 4 active US drug master files and 4 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 Haisen Pharmaceutical FDA-registered?
One site operated by Zhejiang Haisen 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 Haisen Pharmaceutical's last inspection go?
The most recent inspection on record closed on 15 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Zhejiang Haisen Pharmaceutical manufacture?
2 registered sites are on record, in China (Xiangtan Village and China). Every site is listed on this page with the register it came from.
What does Zhejiang Haisen Pharmaceutical make?
5 molecules are on record against Zhejiang Haisen Pharmaceutical, including Atorvastatin, Sucralfate, Escitalopram and Metamizole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Haisen 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 15 November 2024.

Comparable suppliers

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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