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
- Plot No 16 & 17, PHARMEZ Special Economic Zone Sarkhej-Bavla N.H. No. 8A, Vil.: Matoda, Tal.: Sanand, Ahmedabad, GJ 382213, India (IND)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3010661577 · DUNS 650762060
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2024-07-19
- NAIDrug Quality Assurance2023-06-09
- VAIDrug Quality Assurance2019-07-19
- NAIDrug Quality Assurance2018-05-03
- NAIDrug Quality Assurance2017-11-10
- NAIDrug Quality Assurance2015-03-19
Drugs this plant is listed as making
42 distinct drugs across 99 products name this site in their FDA label.
- Acebutolol HydrochlorideAmneal Pharmaceuticals of New York LLC
- AlbuterolAmneal Pharmaceuticals NY LLC
- Alosetron HydrochlorideAmneal Pharmaceuticals of New York LLC
- Bethanechol ChlorideAmneal Pharmaceuticals of New York LLC
- Bumetanidein shortageAmneal Pharmaceuticals NY LLC
- chlordiazepoxide hydrochloride and clidinium bromideAmneal Pharmaceuticals NY LLC
- Cyclobenzaprine HydrochlorideAmneal Pharmaceuticals LLC
- DarunavirAmneal Pharmaceuticals NY LLC
- DeferasiroxAmneal Pharmaceuticals NY LLC
- deflazacortAmneal Pharmaceuticals NY LLC
- DesipramineAmneal Pharmaceuticals NY LLC
- dexamethasoneAmneal Pharmaceuticals NY LLC
- DipyridamoleAmneal Pharmaceuticals of New York LLC
- EltrombopagAmneal Pharmaceuticals NY LLC
- Emtricitabine and Tenofovir Disoproxil FumarateAmneal Pharmaceuticals NY LLC
- ErythromycinAmneal Pharmaceuticals NY LLC
- Ethacrynic AcidAmneal Pharmaceuticals NY LLC
- EtodolacAmneal Pharmaceuticals NY LLC
- EzetimibeAmneal Pharmaceuticals NY LLC
- Ezetimibe and SimvastatinAmneal Pharmaceuticals NY LLC
- fluphenazine hydrochlorideAmneal Pharmaceuticals NY LLC
- Frovatriptan succinateAmneal Pharmaceuticals NY LLC
- Hydroxyzine PamoateNCS HealthCare of KY, LLC dba Vangard Labs
- lenalidomideAmneal Pharmaceuticals NY LLC
- Meclizine HydrochlorideAmneal Pharmaceuticals of New York LLC
- memantineAmneal Pharmaceuticals LLC
- NaproxenAmneal Pharmaceuticals LLC
- Nitrofurantoin MacrocrystalsAmneal Pharmaceuticals of New York LLC
- OseltamivirAmneal Pharmaceuticals NY LLC
- OxaprozinAmneal Pharmaceuticals NY LLC
- PhytonadioneAmneal Pharmaceuticals NY LLC
- PirfenidoneAmneal Pharmaceuticals NY LLC
- Promethazine Hydrochloridein shortageAmneal Pharmaceuticals of New York LLC
- Sevelamer CarbonateAmneal Pharmaceuticals LLC
- SilodosinAmneal Pharmaceuticals NY LLC
- Sulfamethoxazole and TrimethoprimAmneal Pharmaceuticals LLC
- TemazepamAmneal Pharmaceuticals of New York LLC
- Terbutaline SulfateAmneal Pharmaceuticals of New York LLC
- Tetracycline HydrochlorideAmneal Pharmaceuticals NY LLC
- tioproninAmneal Pharmaceuticals NY LLC
- Tramadol HydrochlorideAmneal Pharmaceuticals NY LLC
- VigabatrinAmneal Pharmaceuticals NY 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.