Organization (Industry)
ANI PHARMACEUTICALS, INC.
ClinicalTrials.gov lists ANI PHARMACEUTICALS, INC. as lead sponsor of 12 trials, counting the companies grouped under it. ANI PHARMACEUTICALS, INC. itself has 1 approved asset.
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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 0.4 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers ANI PHARMACEUTICALS, INC. and 1 company grouped under it: 12 lead-sponsored trials (0 its own, 12 in the grouped companies) and 5 legal-entity registrations (3 its own, 2 in the grouped companies).
Related companies are recorded in the same corporate group by GLEIF, ROR or a curator but are not grouped here; they are listed below with their own counts and are not included in the figures above.
Companies grouped under this page (1)
| Company | Lead trials | Legal entities |
|---|---|---|
| Alimera Sciences (Germany) | 12 | 2 |
Disease areas (8)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Arthritis, Gouty | 1 |
| Breast Neoplasms | 1 |
| Gout | 1 |
| Hot Flashes | 1 |
| Uveitis | 1 |
Showing 5 of 8 disease areas.
Trials by start year as sponsor or collaborator (7)
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 | 1 |
| 2022 | 1 |
| 2013 | 1 |
| 2010 | 1 |
| 2008 | 2 |
| 2006 | 1 |
| 2003 | 1 |
Recruitment duration, a model prediction: none of the 5 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Approved assets (1)
| Drug | Trials |
|---|---|
| Estradiol | 1 |
Journals published in (2)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| American heart journal | 1 |
| Obstetrics and gynecology | 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 |
|---|---|---|
| 31 | 9 | 2025-10-14 |
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 | 883,366,000 | 78,337,000 | 51,664,000 |
| 2024 | 614,376,000 | -18,522,000 | 44,581,000 |
| 2023 | 486,816,000 | 18,779,000 | 34,286,000 |
| 2022 | 316,385,000 | -47,896,000 | 22,318,000 |
| 2021 | 216,136,000 | -42,603,000 | 11,369,000 |
| 2020 | 208,475,000 | -22,548,000 | 16,001,000 |
| 2019 | 206,547,000 | 6,094,000 | 19,806,000 |
| 2018 | 201,576,000 | 15,494,000 | 15,388,000 |
| 2017 | 176,842,000 | -1,076,000 | 9,070,000 |
| 2016 | 128,622,000 | 3,934,000 | 2,906,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (27)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2025-03-17 | Royalty / licensing | not disclosed | Sec extracted |
| 2024-09-16 | Other financing | not disclosed | Sec extracted |
| 2024-08-13 | Debt financing | 306 | Sec extracted |
| 2024-08-13 | Debt financing | not disclosed | Sec extracted |
| 2024-08-13 | Debt financing | not disclosed | Sec extracted |
Showing 5 of 27 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 10 |
FDA recalls (13)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 | Class III | 2026-06-02 |
| Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 | Class II | 2026-05-12 |
| Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | Class II | 2022-02-15 |
| Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | Class II | 2022-02-15 |
| Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 | Class II | 2022-02-15 |
Showing 5 of 13 recalls.
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| ANI Pharmaceuticals, Inc. | Baudette, US | FDA, Health Canada |
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 (3)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Mass General Brigham | Co sponsors trial with | 1 |
| Texas Retina Associates (United States) | Co sponsors trial with | 1 |
| Eye Point Pharmaceuticals | Co sponsors trial with | 1 |
Latest dated events (100)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-06-02 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-05-12 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-20 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-10-14 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-07-08 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 100 events.
Biomarker capability evidence (10)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| CSF2 | Trial collaborator | Named in trial exclusion criteria |
| ESR1 | Trial sponsor | Named in trial exclusion criteria |
| TNF | Trial collaborator | Named in trial exclusion criteria |
| AR | Trial collaborator | Mentioned in trial text |
| CASP3 | Trial collaborator | Mentioned in trial text |
Showing 5 of 10 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: active development programs, sponsor delivery record, fda warning letters, fda untitled letters, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.