Suppliers / Anhui Poly Pharm

Anhui Poly Pharm

China Updated 9 July 2026

Anhui Poly Pharm is an API manufacturer based in China. It holds 12 active US drug master files and 5 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 February 2025 as VAI.

12
active US DMFs
5
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 1 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

  • 27 February 2025 VAI US FDA

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

Registered plants

Site FDA FEI
Anqing, China Not on file
China, China 3020871572

What they file, and where

Molecule Regulators Docs
Cyclophosphamide EDQM, US FDA 2
Gadobutrol EDQM, US FDA 2
Voriconazole EDQM, US FDA 2
Allopurinol US FDA 1
Apremilast US FDA 1
Crisaborole US FDA 1
Gadoteric Acid US FDA 1
Gadoteridol US FDA 1
Ioversol US FDA 1
Magnesium US FDA 1
Show all 14 molecules on file
Magnesium Hydroxide EDQM 1
Semaglutide US FDA 1
Sodium Nitroprusside EDQM 1
Tecovirimat US FDA 1

Also appears on these molecule pages

Allopurinol API Crisaborole API Cyclophosphamide API Gadobutrol API Gadoteric Acid API Semaglutide API Voriconazole API Apremilast API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
US FDA None 1

Questions about Anhui Poly Pharm

Does Anhui Poly Pharm hold a US DMF or a CEP?
Anhui Poly Pharm holds 12 active US drug master files 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 Anhui Poly Pharm FDA-registered?
One site operated by Anhui 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 Anhui Poly Pharm's last inspection go?
The most recent inspection on record closed on 27 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Anhui Poly Pharm manufacture?
2 registered sites are on record, in China (Anqing and China). Every site is listed on this page with the register it came from.
What does Anhui Poly Pharm make?
14 molecules are on record against Anhui Poly Pharm, including Cyclophosphamide, Gadobutrol, Voriconazole and Allopurinol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Anhui Poly Pharm'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 27 February 2025.

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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