Suppliers / Zhejiang Hisoar Chuannan Pharmaceutical

Zhejiang Hisoar Chuannan Pharmaceutical

China Updated 9 July 2026

Zhejiang Hisoar Chuannan Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file and 5 valid CEPs across a filed portfolio of 7 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 31 October 2025 as NAI.

1
active US DMFs
5
valid CEPs
3
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
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 31 October 2025 NAI US FDA
  • 2 November 2017 NAI US FDA
  • 8 July 2016 VAI US FDA
  • 26 September 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Taizhou City, China Not on file
Taizhou, China Not on file
China, China 3006545436

What they file, and where

Molecule Regulators Docs
Phenylephrine SFDA (Saudi Arabia) 2
Avibactam US FDA 1
Clindamycin Hydrochloride EDQM 1
Clindamycin Phosphate EDQM 1
Metoprolol EDQM 1
Quetiapine EDQM 1
Repaglinide EDQM 1

Also appears on these molecule pages

Avibactam API Clindamycin API Metoprolol API Phenylephrine API Repaglinide API Quetiapine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Questions about Zhejiang Hisoar Chuannan Pharmaceutical

Does Zhejiang Hisoar Chuannan Pharmaceutical hold a US DMF or a CEP?
Zhejiang Hisoar Chuannan Pharmaceutical holds 1 active US drug master file and 5 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 Hisoar Chuannan Pharmaceutical FDA-registered?
One site operated by Zhejiang Hisoar Chuannan 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 Hisoar Chuannan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 31 October 2025 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Zhejiang Hisoar Chuannan Pharmaceutical manufacture?
3 registered sites are on record, in China (Taizhou City, Taizhou and China). Every site is listed on this page with the register it came from.
What does Zhejiang Hisoar Chuannan Pharmaceutical make?
7 molecules are on record against Zhejiang Hisoar Chuannan Pharmaceutical, including Phenylephrine, Avibactam, Clindamycin Hydrochloride and Clindamycin Phosphate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Hisoar Chuannan Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA and EMA. 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 31 October 2025.

Comparable suppliers

Apitoria Pharma shares 3 molecules Dr Reddy's Laboratories shares 2 molecules Zydus Lifesciences shares 2 molecules Macleods Pharmaceuticals shares 2 molecules Boehringer Ingelheim Pharma Gmbh 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