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Manufacturing facility

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
19 Readington Road Bldg C, Branchburg, New Jersey (NJ) 08876-3520, United States (USA)
Operations here
analysislabelmanufacturepack
FDA identifiers
FEI 3004488497 · DUNS 117359037

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

1 distinct drugs across 1 products name this site in their FDA label.

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.