Suppliers / Zhejiang Haizhou Pharmaceutical

Zhejiang Haizhou Pharmaceutical

China Updated 9 July 2026

Zhejiang Haizhou Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files and 2 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 18 April 2025 as NAI.

5
active US DMFs
2
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 April 2025 NAI US FDA
  • 18 January 2019 VAI US FDA
  • 7 August 2014 NAI US FDA
  • 30 June 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Linhai, China Not on file
China, China 3002917378

What they file, and where

Molecule Regulators Docs
Methocarbamol US FDA 3
Acetylcysteine US FDA 1
Guaifenesin US FDA 1
Iodixanol EDQM 1
Iohexol EDQM 1

Also appears on these molecule pages

Acetylcysteine API Anastrozole contract manufacturing Atorvastatin contract manufacturing Calci contract manufacturing Capecitabine contract manufacturing Dasatinib contract manufacturing Decitabine contract manufacturing Dimethyl contract manufacturing Dorzolamide contract manufacturing Entacapone contract manufacturing Erlotinib contract manufacturing Fexofenadine contract manufacturing
Show 13 more molecule pages
Gefitinib contract manufacturing Glimepiride contract manufacturing Granisetron contract manufacturing Guaifenesin contract manufacturing Iodixanol API Iohexol contract manufacturing Lapatinib contract manufacturing Leucine contract manufacturing Methocarbamol contract manufacturing Prasugrel contract manufacturing Pyrazinamide contract manufacturing Ranolazine contract manufacturing Rosuvastatin contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Zhejiang Haizhou Pharmaceutical

Does Zhejiang Haizhou Pharmaceutical hold a US DMF or a CEP?
Zhejiang Haizhou Pharmaceutical holds 5 active US drug master files and 2 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 Haizhou Pharmaceutical FDA-registered?
One site operated by Zhejiang Haizhou 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 Haizhou Pharmaceutical's last inspection go?
The most recent inspection on record closed on 18 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Zhejiang Haizhou Pharmaceutical manufacture?
2 registered sites are on record, in China (Linhai and China). Every site is listed on this page with the register it came from.
What does Zhejiang Haizhou Pharmaceutical make?
5 molecules are on record against Zhejiang Haizhou Pharmaceutical, including Methocarbamol, Acetylcysteine, Guaifenesin and Iodixanol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Haizhou Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) and 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 18 April 2025.

Comparable suppliers

Seven Star Pharmaceutical shares 3 molecules Granules India shares 2 molecules Suzhou Ryway Biotech shares 2 molecules GE Healthcare shares 2 molecules Zhejiang Starry Pharmaceutical shares 2 molecules

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