Zhejiang Huahai Pharmaceutical Co., Ltd.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- China
- Registered address
- Xunqiao Town, Linhai, Zhejiang 317024, China (CHN)
- Operations here
- api manufacturemanufacture
- FDA identifiers
- FEI 3003999190 · DUNS 530732460
Recent inspection flagged official action
FDA classified an inspection here as OAI (official action indicated) within the last two years — the strongest public warning signal a facility gets. This plant is listed on labels for 28 drugs, 2 already in shortage. A supply problem here can ripple to all of them.
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- OAIDrug Quality Assurance2026-04-24
- OAIDrug Quality Assurance2025-01-24
- NAIDrug Quality Assurance2021-07-02
- OAIDrug Quality Assurance2019-05-31
- VAIDrug Quality Assurance2016-11-18
- NAIDrug Quality Assurance2015-03-27
- NAIDrug Quality Assurance2013-08-09
- NAIDrug Quality Assurance2010-09-02
Drugs this plant is listed as making
28 distinct drugs across 86 products name this site in their FDA label.
- aripiprazoleSolco Healthcare U.S., LLC
- DoxycyclineSolco Healthcare US,LLC
- Doxycycline HyclateSolco Healthcare US LLC
- DuloxetineSolco Healthcare US, LLC
- EntecavirSolco Healthcare LLC
- EscitalopramBluePoint Laboratories
- Esomeprazole magnesiumSolco Healthcare US LLC
- fingolimodSolco Healthcare US, LLC
- IrbesartanSolco Healthcare U.S., LLC
- lamotrigine extended releasePar Health USA, LLC
- levetiracetamSolco Healthcare US, LLC
- losartan potassium and hydrochlorothiazideSolco Healthcare US, LLC
- metformin hydrochlorideSolco Healthcare US, LLC.
- nebivololSolco Healthcare US, LLC
- olmesartan medoxomilSolco Healthcare US, LLC.
- olmesartan medoxomil and hydrochlorothiazideSolco Healthcare US, LLC
- paroxetineSolco Healthcare LLC
- paroxetine hydrochloride hemihydrateSolco Healthcare US, LLC
- PemetrexedSolco Healthcare US, LLC
- quetiapineSolco Healthcare U.S., LLC
- quinaprilin shortageSolco Healthcare US, LLC
- rocuronium bromidein shortageSolco Healthcare US, LLC
- roflumilastSolco Healthcare US, LLC.
- ropiniroleSolco Healthcare US, LLC
- tadalafilSolco Healthcare US, LLC
- TelmisartanSolco Healthcare US, LLC
- ticagrelorSolco Healthcare U.S., LLC
- valsartan and hydrochlorothiazideSolco Healthcare US, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.