Suppliers / Hainan Poly Pharm

Hainan Poly Pharm

China Updated 9 July 2026

Hainan Poly Pharm is an API and finished-dose manufacturer based in China. It holds 7 active US drug master files across a filed portfolio of 9 molecules. Its filings concentrate with NMPA (CN), US FDA and SFDA (Saudi Arabia). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 June 2023 as VAI.

7
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
85
filings across 6 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

  • 30 June 2023 VAI US FDA
  • 19 September 2019 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 22 January 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
Hainan Province, United Arab Emirates Not on file
Haikou, China Not on file
China, China 3005115952

What they file, and where

Molecule Regulators Docs
Acyclovir US FDA 1
Amiodarone US FDA 1
Bumetanide US FDA 1
Dobutamine US FDA 1
Esomeprazole US FDA 1
Ganciclovir SFDA (Saudi Arabia) 1
Glycopyrronium US FDA 1
Sodium Nitroprusside SFDA (Saudi Arabia) 1
Trimebutine US FDA 1

Also appears on these molecule pages

Acyclovir API Amiodarone API Brivaracetam finished dose Bumetanide API Calcium Folinate finished dose Cyclophosphamide finished dose Daptomycin finished dose Dobutamine API Eptifibatide finished dose Esomeprazole API Ganciclovir API Glycopyrronium API
Show 4 more molecule pages
Leucovorin finished dose Phenylephrine finished dose Trimebutine API Voriconazole finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
NMPA (CN) 49 None
US FDA 17 1
SFDA (Saudi Arabia) 9 None
MINSA (CR) 6 None
EDE (AE) 2 None
NPRA (MY) 2 None
EMA None 1

Questions about Hainan Poly Pharm

Does Hainan Poly Pharm hold a US DMF or a CEP?
Hainan Poly Pharm holds 7 active US drug master files. 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 Hainan Poly Pharm FDA-registered?
One site operated by Hainan Poly Pharm 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 Hainan Poly Pharm's last inspection go?
The most recent inspection on record closed on 30 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Hainan Poly Pharm manufacture?
3 registered sites are on record, in United Arab Emirates and China (Hainan Province, Haikou and China). Every site is listed on this page with the register it came from.
What does Hainan Poly Pharm make?
9 molecules are on record against Hainan Poly Pharm, including Acyclovir, Amiodarone, Bumetanide and Dobutamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hainan Poly Pharm'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 VAI, on 30 June 2023.

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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