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
- 47 Colonial Dr Bldg B, Piscataway, New Jersey (NJ) 08854-4113, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3008861605 · DUNS 079389286
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIDrug Quality Assurance2026-04-30
- NAIBioresearch Monitoring2025-03-28
- NAIDrug Quality Assurance2023-11-21
- VAIDrug Quality Assurance2022-02-10
- NAIBioresearch Monitoring2018-10-19
- NAIDrug Quality Assurance2016-02-19
- NAIDrug Quality Assurance2014-10-23
- NAIDrug Quality Assurance2013-06-26
Drugs this plant is listed as making
11 distinct drugs across 16 products name this site in their FDA label.
- AcyclovirAmneal Pharmaceuticals LLC
- BexaroteneAmneal Pharmaceuticals NY LLC
- Clindamycin Phosphatein shortageAmneal Pharmaceuticals NY LLC
- DasponeAmneal Pharmaceuticals NY LLC
- Diclofenac Sodium and MisoprostolAmneal Pharmaceuticals LLC
- Doxepin HydrochlorideAmneal Pharmaceuticals NY LLC
- Estradiol TransdermalAmneal Pharmaceuticals NY LLC
- LidocaineAmneal Pharmaceuticals LLC
- MupirocinAmneal Pharmaceuticals NY LLC
- PenciclovirAmneal Pharmaceuticals NY LLC
- TretinoinAmneal 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.