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.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
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 (17)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Amneal Pharmaceuticals Private Limited | Mehsana, IN | FDA, Health Canada | Amneal Pharmaceuticals Private Limited |
| Amneal Pharmaceuticals Private Limited | Ahmedabad, IN | EMA, FDA | Amneal Pharmaceuticals Private Limited |
| Amneal Ireland Limited | Cashel, IE | EMA, FDA | Amneal Ireland Limited |
| Amneal Oncology Private Limited | Mahaboobnagar, IN | EMA, FDA, Health Canada | Amneal Oncology Private Limited |
| Amneal Pharmaceuticals, LLC | East Hanover, US | FDA |
Showing 5 of 17 sites.
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.