Organization (Industry)
Amneal Pharmaceuticals, Inc.
ClinicalTrials.gov lists Amneal Pharmaceuticals, Inc. as lead sponsor of 35 trials, counting the companies grouped under it. Amneal Pharmaceuticals, Inc. itself has 8 active development programs and 2 approved assets.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 0 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Amneal Pharmaceuticals, Inc. and 5 companies grouped under it: 35 lead-sponsored trials (12 its own, 23 in the grouped companies) and 6 legal-entity registrations (4 its own, 2 in the grouped companies).
Companies grouped under this page (5)
Shown in this order: most lead trials first.
| Company | Lead trials | Legal entities |
|---|---|---|
| Impax Laboratories, LLC | 20 | 0 |
| Amneal Ireland Limited | 3 | 0 |
| AMNEAL ONCOLOGY PRIVATE LIMITED | 0 | 1 |
| AMNEAL PHARMACEUTICALS PRIVATE LIMITED | 0 | 1 |
| Amneal EU, Limited | 0 | 0 |
Disease areas (16)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Glaucoma | 2 |
| Glaucoma, Open-Angle | 2 |
| Parkinson Disease | 2 |
| Arthritis, Rheumatoid | 1 |
| Gastrointestinal Stromal Tumors | 1 |
Showing 5 of 16 disease areas.
Trials by start year as sponsor or collaborator (8)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2025 | 2 |
| 2024 | 2 |
| 2022 | 1 |
| 2016 | 1 |
| 2014 | 4 |
| 2013 | 1 |
| 2012 | 3 |
| 2009 | 1 |
Recruitment duration, a model prediction: 2 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (8)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) | Glaucoma | Phase 3 | 1 |
| Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution) | Glaucoma, Open-Angle | Phase 3 | 1 |
| Test - Bimatoprost 0.01% Ophthalmic Solution | Glaucoma | Phase 3 | 1 |
| Test - Bimatoprost 0.01% Ophthalmic Solution | Glaucoma, Open-Angle | Phase 3 | 1 |
| Bimatoprost Ophthalmic Solution 0.01% | Glaucoma | Phase 1 | 1 |
Showing 5 of 8 active programs.
Approved assets (2)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Phenazopyridine | 1 |
| Diclofenac Gel | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 1 of 1 hit target (n=1) | 1 of 1 on time (n=1) |
Journals published in (5)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| BJOG : an international journal of obstetrics and gynaecology | 1 |
| Clinical neuropharmacology | 1 |
| European journal of obstetrics, gynecology, and reproductive biology | 1 |
| JAMA neurology | 1 |
| Parkinsonism & related disorders | 1 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 43 | 22 | 2025-11-18 |
SEC-reported annual financials (11)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 3,018,760,000 | 72,057,000 | 186,175,000 |
| 2024 | 2,793,957,000 | -116,886,000 | 190,714,000 |
| 2023 | 2,393,607,000 | -83,993,000 | 163,950,000 |
| 2022 | 2,212,304,000 | -270,584,000 | 195,688,000 |
| 2021 | 2,093,669,000 | 13,163,000 | 201,847,000 |
| 2020 | 1,992,523,000 | 67,791,000 | 179,930,000 |
| 2019 | 1,626,373,000 | -603,573,000 | 188,049,000 |
| 2018 | 1,662,991,000 | -19,744,000 | 194,190,000 |
| 2017 | 1,033,654,000 | 0 | 171,420,000 |
| 2016 | 1,018,225,000 | 0 | 179,019,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (24)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-08-03 | Debt financing | not disclosed | Sec extracted |
| 2026-08-03 | Debt financing | not disclosed | Sec extracted |
| 2026-07-31 | Other financing | not disclosed | Sec extracted |
| 2026-04-21 | Other financing | 375,000,000 | Sec extracted |
| 2026-02-02 | Debt financing | not disclosed | Sec extracted |
Showing 5 of 24 events.
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50. | Class II | 2019-08-28 |
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Amneal Pharmaceuticals, LLC | East Hanover, US | FDA | |
| Amneal Pharmaceuticals LLC | Branchburg, US | FDA |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | not disclosed | not disclosed |
Organization relationships (27)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Accutest Research Laboratories (I) Pvt. Ltd. | Co sponsors trial with | 2 |
| Hikma Pharmaceuticals (Germany) | Co sponsors trial with | 1 |
| Boehringer Ingelheim (Germany) | Co sponsors trial with | 1 |
| Qilu Pharmaceutical Co., Ltd. (China) | Co sponsors trial with | 1 |
| Laurus labs (India) | Co sponsors trial with | 1 |
Showing 5 of 27 relationships.
Latest dated events (84)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-08-03 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-08-03 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-07-31 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-04-21 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-02-02 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
Showing 5 of 84 events.
Biomarker capability evidence (30)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| COMT | Trial collaborator | Named in trial inclusion criteria |
| COMT | Trial collaborator | Named in trial inclusion criteria |
| PAPOLA | Trial sponsor | Named in trial inclusion criteria |
| REG3A | Trial sponsor | Named in trial inclusion criteria |
| ACE | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 30 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: related companies not grouped here, fda warning letters, fda untitled letters, fda inspection record, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.