Hainan Poly Pharm. 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
- Guilinyang Economic Development Zone, Meilan District, Haikou, Hainan 571127, China (CHN)
- Operations here
- analysisapi manufacturelabelmanufacturepack
- FDA identifiers
- FEI 3005115952 · DUNS 654561638
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-06-30
- VAIDrug Quality Assurance2019-09-19
- VAIDrug Quality Assurance2016-01-29
- VAIDrug Quality Assurance2014-01-22
Drugs this plant is listed as making
26 distinct drugs across 64 products name this site in their FDA label.
- Azithromycin DihydrateSlate Run Pharmaceuticals
- bivalirudinSlate Run Pharmaceuticals, LLC
- brivaracetamHainan Poly Pharm. Co., Ltd.
- Cisatracurium besylateSlate Run Pharmaceuticals, LLC
- Cyclophosphamide for InjectionHainan Poly Pharm. Co., Ltd.
- daptomycinHainan Poly Pharm., Co., Ltd.
- Dicyclomine HydrochlorideSlate Run Pharmaceuticals, LLC
- dobutaminein shortageSlate Run Pharmaceuticals
- eptifibatideSlate Run Pharmaceuticals, LLC
- gadobutrolSlate Run Pharmaceuticals, LLC
- gadoterate meglumineSlate Run Pharmaceuticals, LLC
- GadoteridolSlate Run Pharmaceuticals, LLC
- iopamidolSlate Run Pharmaceuticals, LLC
- lacosamideSintetica US LLC
- leucovorin calciumSlate Run Pharmaceuticals, LLC
- levetiracetamTAGI Pharma, Inc.
- levoleucovorin injectionHainan Poly Pharm. Co., Ltd.
- lincomycinSlate Run Pharmaceuticals, LLC
- methocarbamolSlate Run Pharmaceuticals, LLC
- Phenylephrine HydrochlorideHainan Poly Pharm. Co., Ltd.
- Sodium NitroprussideHainan Poly Pharm. Co., Ltd.
- sodium nitroprusside in 0.9% sodium chlorideSlate Run Pharmaceuticals, LLC
- tobramycinSlate Run Pharmaceuticals, LLC
- Vancomycin HydrochlorideSlate Run Pharmaceuticals, LLC
- VoriconazoleHainan Poly Pharm. Co., Ltd.
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.