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, ANVISA (Brazil) and US FDA. 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
Linhai, China Not on file
Taizhou, 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

Ambrisentan API Amisulpride API Azelaic Acid API Benazepril API Benserazide API Brexpiprazole API Canagliflozin API Candesartan API Candesartan Cilexetil API Captopril API Cariprazine API Carvedilol API
Show 53 more molecule pages
Citalopram API Dabigatran Etexilate Mesilate API Dapagliflozin Propanediol API Donepezil API Duloxetine API Efavirenz API Elagolix API Enalapril API Entecavir API Eprosartan API Favipiravir API Febuxostat API Fingolimod API Gefitinib API Hydrochlorothiazide API Irbesartan API Ketotifen API Levodopa API Levomilnacipran API Lisinopril API Losartan API Metoprolol API Nebivolol API Nevirapine API Nicardipine API Paroxetine API Perindopril API Perindopril Tert-Butylamine API Pioglitazone API Quinapril API Ramipril API Ranolazine API Risperidone API Rocuronium API Ropinirole API Safinamide API Silodosin API Tadalafil API Telmisartan API Tolvaptan API Topiramate API Torasemide API Voriconazole API Vortioxetine API Valsartan API Clopidogrel API Gabapentin API Levetiracetam API Pregabalin API Rivaroxaban API Olmesartan Medoxomil API Aripiprazole API Brivaracetam API

Filings and GMP by regulator

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

Questions about Zhejiang Huahai Pharmaceutical

Does Zhejiang Huahai Pharmaceutical hold a US DMF or a CEP?
Zhejiang Huahai Pharmaceutical holds 86 active US drug master files and 68 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 Huahai Pharmaceutical FDA-registered?
2 sites operated by Zhejiang Huahai Pharmaceutical carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Zhejiang Huahai Pharmaceutical's last inspection go?
The most recent inspection on record closed on 24 January 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 3 closed as OAI.
Where does Zhejiang Huahai Pharmaceutical manufacture?
5 registered sites are on record, in China (Zhejiang, Linhai and Taizhou among others). Every site is listed on this page with the register it came from.
What does Zhejiang Huahai Pharmaceutical make?
30 molecules are on record against Zhejiang Huahai Pharmaceutical, including Levetiracetam, Paroxetine, Telmisartan and Valsartan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Huahai Pharmaceutical's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) 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

  • 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.

Comparable suppliers

Apitoria Pharma shares 32 molecules Hetero shares 26 molecules Zydus Lifesciences shares 25 molecules Dr Reddy's Laboratories shares 22 molecules Alembic Pharmaceuticals shares 19 molecules

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