Suppliers / AMHWA Biopharm Co.,Ltd

AMHWA Biopharm Co.,Ltd

China Updated 9 July 2026

AMHWA Biopharm Co.,Ltd is an API manufacturer based in China. It holds one active US drug master file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 September 2024 as NAI.

1
active US DMFs
0
valid CEPs
1
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 September 2024 NAI US FDA

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

Registered plants

Site FDA FEI
China, China 3011575996

What they file, and where

Molecule Regulators Docs
Hyaluronic Acid US FDA 1

Also appears on these molecule pages

Hyaluronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about AMHWA Biopharm Co.,Ltd

Does AMHWA Biopharm Co.,Ltd hold a US DMF or a CEP?
AMHWA Biopharm Co.,Ltd holds 1 active US drug master file. 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 AMHWA Biopharm Co.,Ltd FDA-registered?
One site operated by AMHWA Biopharm Co.,Ltd 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 AMHWA Biopharm Co.,Ltd's last inspection go?
The most recent inspection on record closed on 12 September 2024 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does AMHWA Biopharm Co.,Ltd manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does AMHWA Biopharm Co.,Ltd make?
1 molecule is on record against AMHWA Biopharm Co.,Ltd, including Hyaluronic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise AMHWA Biopharm Co.,Ltd'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 NAI, on 12 September 2024.

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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