Amneal Pharmaceuticals, LLC
Nasdaq AMRX · Bridgewater, NJ
Works in Musculoskeletal · Ophthalmology
Amneal Pharmaceuticals, LLC is a clinical trial sponsor based in Bridgewater, NJ, listed as Nasdaq AMRX. It has 1 active clinical trial with 168 planned participants, in Musculoskeletal and Ophthalmology. Since 2021 it has completed 2 trials and stopped 0 early. Its FDA record on file shows 2 inspections, 1 warning letter and 2 recalls.
Trial track record · since 2021
FDA record
Recent FDA actions
Financials · Nasdaq AMRX
Pipeline · 1 active trial
| Stage | Trial | Status |
|---|---|---|
On the market
11 approved drug applications with a product on the market.
Questions about Amneal Pharmaceuticals, LLC
Yes. FDA has published 1 warning letter naming Amneal Pharmaceuticals, LLC; the latest was posted on 2025-09-02. Each letter links to FDA's own posting.
FDA has posted 2 inspection classifications naming Amneal Pharmaceuticals, LLC (2 NAI). The latest inspection ended on 2026-08-28 and was classified NAI (no action indicated). FDA posts a classification after its review, often months after the inspection ended.
Yes. FDA's enforcement reports list 2 recalls by Amneal Pharmaceuticals, LLC; the latest, reported on 2026-10-07, is a Class II recall.
Amneal Pharmaceuticals, LLC is lead sponsor of 1 active clinical trial on ClinicalTrials.gov, with 168 planned participants, in Musculoskeletal, Ophthalmology. Since 2021 it has completed 2 trials and stopped 0 early.
Amneal Pharmaceuticals, LLC is based in Bridgewater, NJ and is listed as Nasdaq AMRX. The address is the one on its SEC filings, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Amneal Pharmaceuticals, LLC; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-02-19.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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