Suppliers / Zhejiang Hengkang Pharmaceutical

Zhejiang Hengkang Pharmaceutical

China 10 employees Updated 9 July 2026

Zhejiang Hengkang Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 9 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as NAI.

3
active US DMFs
9
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
1 of 1 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

  • 7 March 2025 NAI US FDA

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

Registered plants

Site FDA FEI
Sanmen, China Not on file
China, China 3022190702

What they file, and where

Molecule Regulators Docs
Mesalazine EDQM, US FDA 3
Deferasirox EDQM, US FDA 2
Tenoxicam EDQM 2
Acemetacin EDQM 1
Amiodarone Hydrochloride EDQM 1
Benserazide EDQM 1
Benserazide Hydrochloride EDQM 1
Eltrombopag US FDA 1

Also appears on these molecule pages

Amiodarone API Benserazide API Deferasirox API Eltrombopag API Mesalamine API Mesalazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2
US FDA None 1

Questions about Zhejiang Hengkang Pharmaceutical

Does Zhejiang Hengkang Pharmaceutical hold a US DMF or a CEP?
Zhejiang Hengkang Pharmaceutical holds 3 active US drug master files and 9 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 Hengkang Pharmaceutical FDA-registered?
One site operated by Zhejiang Hengkang 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 Hengkang Pharmaceutical's last inspection go?
The most recent inspection on record closed on 7 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Zhejiang Hengkang Pharmaceutical manufacture?
2 registered sites are on record, in China (Sanmen and China). Every site is listed on this page with the register it came from.
What does Zhejiang Hengkang Pharmaceutical make?
8 molecules are on record against Zhejiang Hengkang Pharmaceutical, including Mesalazine, Deferasirox, Tenoxicam and Acemetacin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Hengkang Pharmaceutical's GMP?
Current GMP certificates are on record from EMA 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 7 March 2025.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates