Amneal Pharmaceuticals, LLC
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
- United States
- Registered address
- 131 Chambers Brook Rd Bldg A, Branchburg, New Jersey (NJ) 08876-3587, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3004488497 · DUNS 963900878
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2024-02-08
- VAIDrug Quality Assurance2019-02-21
- VAIDrug Quality Assurance2017-07-27
- VAIDrug Quality Assurance2015-10-16
- NAIDrug Quality Assurance2013-10-17
- NAIDrug Quality Assurance2011-11-15
- NAIDrug Quality Assurance2010-07-27
- VAIDrug Quality Assurance2008-12-17
Drugs this plant is listed as making
25 distinct drugs across 27 products name this site in their FDA label.
- AripiprazoleAmneal Pharmaceuticals LLC
- AtovaquoneAmneal Pharmaceuticals LLC
- AzelastineAmneal Pharmaceuticals LLC
- Clindamycin Palmitate HydrochlorideAmneal Pharmaceuticals LLC
- DiclofenacAmneal Pharmaceuticals LLC
- EnalaprilAmneal Pharmaceuticals NY LLC
- EscitalopramAmneal Pharmaceuticals LLC
- FelbamateAmneal Pharmaceuticals LLC
- GabapentinAmneal Pharmaceuticals LLC
- ItraconazoleAmneal Pharmaceuticals LLC
- MometasoneAmneal Pharmaceuticals LLC
- NaproxenAmneal Pharmaceuticals NY LLC
- NitrofurantoinAmneal Pharmaceuticals LLC
- Olopatadine HydrochlorideAmneal Pharmaceuticals LLC
- OndansetronAmneal Pharmaceuticals LLC
- OxcarbazepineAmneal Pharmaceuticals LLC
- Prednisolone Sodium PhosphateAmneal Pharmaceuticals NY LLC
- Promethazine and PhenylephrineAmneal Pharmaceuticals LLC
- Promethazine, Phenylephrine, CodeineAmneal Pharmaceuticals LLC
- Pyridostigmine BromideAmneal Pharmaceuticals NY LLC
- RisperidoneAmneal Pharmaceuticals LLC
- SpironolactoneAmneal Pharmaceuticals NY LLC
- Sucralfate OralAmneal Pharmaceuticals LLC
- Vancomycin HydrochlorideAmneal Pharmaceuticals NY LLC
- VoriconazoleAmneal 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.