Suppliers / Zhejiang Huahai Pharmaceutical

Zhejiang Huahai Pharmaceutical

China 600521.SS 468 employees Updated 9 July 2026

Zhejiang Huahai Pharmaceutical is an API manufacturer based in China. It holds 86 active US drug master files and 68 valid CEPs. Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 January 2025 as OAI.

86
active US DMFs
68
valid CEPs
5
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 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

  • 24 January 2025 OAI US FDA
  • 20 November 2024 VAI US FDA
  • 29 July 2021 NAI US FDA
  • 2 July 2021 NAI US FDA
  • 31 May 2019 OAI US FDA
  • 3 August 2018 OAI US FDA
  • 19 May 2017 VAI US FDA
  • 18 November 2016 VAI US FDA

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

Registered plants

Site FDA FEI
ZHEJIANG, China Not on file
Taizhou, China Not on file
Linhai, China Not on file
China, China 3003885745
China, China 3003999190

What they file, and where

Molecule Regulators Docs
Levetiracetam EDQM, SFDA (Saudi Arabia), US FDA 5
Paroxetine EDQM, SFDA (Saudi Arabia), US FDA 5
Telmisartan EDQM, SFDA (Saudi Arabia), US FDA 5
Valsartan EDQM, SFDA (Saudi Arabia), US FDA 5
Captopril EDQM, SFDA (Saudi Arabia), US FDA 4
Nevirapine EDQM, US FDA 4
Olmesartan Medoxomil EDQM, SFDA (Saudi Arabia) 4
Pregabalin EDQM, SFDA (Saudi Arabia), US FDA 4
Rivaroxaban EDQM, SFDA (Saudi Arabia), US FDA 4
Aripiprazole EDQM, SFDA (Saudi Arabia), US FDA 3
Show all 30 molecules on file
Brivaracetam EDQM, US FDA 3
Candesartan Cilexetil EDQM, SFDA (Saudi Arabia) 3
Carvedilol EDQM, US FDA 3
Duloxetine EDQM, SFDA (Saudi Arabia), US FDA 3
Enalapril EDQM, SFDA (Saudi Arabia), US FDA 3
Fosinopril EDQM, SFDA (Saudi Arabia), US FDA 3
Gabapentin EDQM, US FDA 3
Hydrochlorothiazide EDQM, SFDA (Saudi Arabia), US FDA 3
Irbesartan EDQM, SFDA (Saudi Arabia), US FDA 3
Lisinopril EDQM, SFDA (Saudi Arabia), US FDA 3
Losartan EDQM, SFDA (Saudi Arabia), US FDA 3
Pioglitazone EDQM, SFDA (Saudi Arabia), US FDA 3
Tadalafil EDQM, SFDA (Saudi Arabia), US FDA 3
Voriconazole EDQM, SFDA (Saudi Arabia), US FDA 3
Ambrisentan SFDA (Saudi Arabia), US FDA 2
Benazepril EDQM, US FDA 2
Citalopram SFDA (Saudi Arabia), US FDA 2
Citalopram Hydrobromide EDQM 2
Clofazimine EDQM, US FDA 2
Clopidogrel EDQM, US FDA 2

Also appears on these molecule pages

Candesartan API Carvedilol API Citalopram API Duloxetine API Enalapril API Febuxostat API Hydrochlorothiazide API Irbesartan API Levodopa API Lisinopril API Losartan API Metoprolol API
Show 17 more molecule pages
Nebivolol API Paroxetine API Perindopril API Pioglitazone API Ramipril API Risperidone API Tadalafil API Telmisartan API Tolvaptan API Topiramate API Valsartan API Clopidogrel API Gabapentin API Levetiracetam API Pregabalin API Rivaroxaban API Olmesartan Medoxomil API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 1 None
EMA None 5
US FDA None 1
ANVISA (Brazil) None 1

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Open risk flags

  • 98 active litigation matters are on record.
  • One recent serious compliance event is on record.
  • The most recent inspection outcome was OAI, on 24 January 2025.

Sources on this page

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