Company profile
AMNEAL PHARMACEUTICALS, INC.
NASDAQ:AMRXBiotechnology: Pharmaceutical Preparations
Drug pipeline (345)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| ABIRATERONE ACETATE | approved | — | 26 | approved |
| ACEBUTOLOL HYDROCHLORIDE | approved | — | 0 | — |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | approved | — | 78 | approved |
| ACTIVELLA | approved | — | 21 | approved |
| ACYCLOVIR | approved | — | 1 | approved |
Revenue is the latest quarter the company reported for that product, from SEC filings; a fourth quarter is the year less nine months when no filing states one. Trial counts are of the product's ingredients, deduplicated by trial, so products sharing an ingredient share trials.
Clinical trials (15)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT03562949 | phase3 | terminated | 2018-12-06 | 2019-08-02 | Amneal Ireland Limited | A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol |
| NCT06267274 | phase1 | unknown | 2024-04-01 | 2025-03-01 | Amneal Pharmaceuticals, LLC | A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes |
| NCT03562923 | phase3 | unknown | 2018-10-01 | 2019-05-01 | Amneal Ireland Limited | A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50 |
| NCT02940561 | phase1 | unknown | 2016-08-01 | 2016-10-01 | Amneal Pharmaceuticals, LLC | BE Study in Patients - Methotrexate Tablets |
| NCT02072954 | phase2_3 | completed | 2013-11-01 | 2014-02-01 | Amneal Pharmaceuticals, LLC | Bioequivalence Fasting Study in Patients |
FDA applications (451)
| Application | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| NDA 220790 | 2026-07-09 | NDA | AMNEAL EU LTD | |||||
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| ANDA 211000 | 2026-06-08 | ANDA | AMNEAL EU LTD | |||||
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| ANDA 219099 | 2026-06-02 | ANDA | AMNEAL EU LTD | |||||
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| ANDA 217734 | 2026-06-01 | ANDA | AMNEAL EU LTD | |||||
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| ANDA 217497 | 2026-05-14 | ANDA | AMNEAL PHARMACEUTICALS LLC | |||||
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