Amneal Pharmaceuticals Private Limited
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
- India
- Registered address
- Survey No.634, 637 To 641, Near Hotel Kankavati Sarkhej-Bavla Highway, Village Rajoda, Tal Bavla, Ahmedabad, Gujarat 382220, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3008223599 · DUNS 915076126
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-01-24
- NAIDrug Quality Assurance2023-07-14
- NAIDrug Quality Assurance2020-02-21
- VAIDrug Quality Assurance2019-05-24
- NAIDrug Quality Assurance2018-08-24
- NAIDrug Quality Assurance2017-09-22
- NAIDrug Quality Assurance2017-04-12
- VAIDrug Quality Assurance2015-01-30
- VAIDrug Quality Assurance2012-08-17
Drugs this plant is listed as making
50 distinct drugs across 117 products name this site in their FDA label.
- AbirateroneAmneal Pharmaceuticals NY LLC
- AripiprazoleAmneal Pharmaceuticals LLC
- BudesonideAmneal Pharmaceuticals of New York LLC
- CARBIDOPA and LEVODOPAAmneal Pharmaceuticals NY LLC
- Carvedilol PhosphateAmneal Pharmaceuticals of New York LLC
- Chloroquine PhosphateAmneal Pharmaceuticals of New York LLC
- Colesevelam hydrochlorideAmneal Pharmaceuticals of New York LLC
- Dimethyl FumarateAmneal Pharmaceuticals NY LLC
- Divalproex SodiumAmneal Pharmaceuticals LLC
- Doxepin HydrochlorideAmneal Pharmaceuticals NY LLC
- DoxycyclineAmneal Pharmaceuticals NY LLC
- ErythromycinAmneal Pharmaceuticals NY LLC
- EzetimibeAmneal Pharmaceuticals NY LLC
- FamotidineAmneal Pharmaceuticals NY LLC
- Fenofibric AcidAmneal Pharmaceuticals of New York LLC
- Flecainide AcetateAmneal Pharmaceuticals of New York LLC
- Fludrocortisone AcetateAmneal Pharmaceuticals of New York LLC
- Fosfomycin TromethamineAmneal Pharmaceuticals NY LLC
- Frovatriptan succinateAmneal Pharmaceuticals NY LLC
- hydrocortisoneAmneal Pharmaceuticals of New York LLC
- Hydroxyzine PamoateNCS HealthCare of KY, LLC dba Vangard Labs
- IrbesartanAmneal Pharmaceuticals LLC
- LacosamideAmneal Pharmaceuticals of New York LLC
- LamotrigineAmneal Pharmaceuticals of New York LLC
- Lurasidone HydrochlorideAmneal Pharmaceuticals LLC
- MetaxaloneAmneal Pharmaceuticals LLC
- Metformin HydrochlorideAmneal Pharmaceuticals of New York LLC
- Mycophenolate MofetilAmneal Pharmaceuticals NY LLC
- NaproxenAmneal Pharmaceuticals LLC
- NiacinAmneal Pharmaceuticals LLC
- OseltamivirAmneal Pharmaceuticals NY LLC
- PitavastatinAmneal Pharmaceuticals LLC
- PrasugrelAmneal Pharmaceuticals LLC
- Pyridostigmine BromideAmneal Pharmaceuticals of New York LLC
- QuinineAmneal Pharmaceuticals LLC
- RabeprazoleAmneal Pharmaceuticals LLC
- Rimantadine HydrochlorideAmneal Pharmaceuticals of New York LLC
- Sevelamer CarbonateAmneal Pharmaceuticals LLC
- SildenafilAmneal Pharmaceuticals NY LLC
- SpironolactoneAmneal Pharmaceuticals of New York LLC
- SucralfateAmneal Pharmaceuticals NY LLC
- TelmisartanAmneal Pharmaceuticals LLC
- Tramadol HydrochlorideAmneal Pharmaceuticals NY LLC
- Ultramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York LLC
- ValsartanAmneal Pharmaceuticals of New York LLC
- VigabatrinAmneal Pharmaceuticals NY LLC
- WarfarinAmneal Pharmaceuticals 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.