Suppliers / Zhejiang Chiral Medicine Chemicals

Zhejiang Chiral Medicine Chemicals

China 3 employees Updated 9 July 2026

Zhejiang Chiral Medicine Chemicals is an API manufacturer based in China. It holds 4 active US drug master files and 6 valid CEPs 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 14 March 2025 as VAI.

4
active US DMFs
6
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 March 2025 VAI US FDA
  • 12 September 2019 VAI US FDA
  • 13 October 2017 NAI US FDA
  • 11 August 2016 VAI US FDA
  • 29 January 2013 VAI US FDA
  • 19 August 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
Hangzhou, China Not on file
China, China 3003878169

What they file, and where

Molecule Regulators Docs
Carbidopa EDQM, US FDA 3
Etodolac EDQM, SFDA (Saudi Arabia), US FDA 3
Gabapentin EDQM, SFDA (Saudi Arabia), US FDA 3
Methyldopa EDQM, US FDA 3

Also appears on these molecule pages

Carbidopa API Etodolac API Gabapentin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Chiral Medicine Chemicals

Does Zhejiang Chiral Medicine Chemicals hold a US DMF or a CEP?
Zhejiang Chiral Medicine Chemicals holds 4 active US drug master files and 6 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 Chiral Medicine Chemicals FDA-registered?
One site operated by Zhejiang Chiral Medicine Chemicals 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 Chiral Medicine Chemicals's last inspection go?
The most recent inspection on record closed on 14 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Zhejiang Chiral Medicine Chemicals manufacture?
2 registered sites are on record, in China (Hangzhou and China). Every site is listed on this page with the register it came from.
What does Zhejiang Chiral Medicine Chemicals make?
4 molecules are on record against Zhejiang Chiral Medicine Chemicals, including Carbidopa, Etodolac, Gabapentin and Methyldopa. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Chiral Medicine Chemicals'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 14 March 2025.

Comparable suppliers

Hetero shares 2 molecules Divi's Laboratories shares 2 molecules Zhejiang Yongtai Chiral Medicine Technology shares 2 molecules Apitoria Pharma shares 1 molecule Olon 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