Organization (Industry)
AMPHASTAR PHARMACEUTICALS, INC.
ClinicalTrials.gov lists AMPHASTAR PHARMACEUTICALS, INC. as lead sponsor of 21 trials, counting the companies grouped under it. AMPHASTAR PHARMACEUTICALS, INC. itself has 7 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: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 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 AMPHASTAR PHARMACEUTICALS, INC. and 1 company grouped under it: 21 lead-sponsored trials (21 its own, 0 in the grouped companies) and 4 legal-entity registrations (3 its own, 1 in the grouped companies).
Companies grouped under this page (1)
| Company | Lead trials | Legal entities |
|---|---|---|
| INTERNATIONAL MEDICATION SYSTEMS, LIMITED | 0 | 1 |
Disease areas (7)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Asthma | 18 |
| Dyspnea | 5 |
| Bronchial Spasm | 4 |
| Respiratory Sounds | 3 |
| Pulmonary Disease, Chronic Obstructive | 2 |
Showing 5 of 7 disease areas.
Trials by start year as sponsor or collaborator (10)
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 |
|---|---|
| 2026 (partial year) | 1 |
| 2022 | 1 |
| 2019 | 1 |
| 2014 | 2 |
| 2012 | 4 |
| 2011 | 3 |
| 2010 | 5 |
| 2009 | 1 |
| 2008 | 2 |
| 2007 | 1 |
Recruitment duration, a model prediction: none of the 21 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Approved assets (7)
Shown in this order: max phase first.
| Drug | Trials |
|---|---|
| Albuterol | 2 |
| Epinephrine | 2 |
| Ventolin | 1 |
| Insulin Aspart | 2 |
| Histamine | 1 |
Showing 5 of 7 approved assets.
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 |
|---|---|
| 3 of 3 hit target (n=3) | 3 of 3 on time (n=3) |
Journals published in (26)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of aerosol medicine and pulmonary drug delivery | 3 |
| The European respiratory journal | 3 |
| Anaesthesia | 2 |
| Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology | 2 |
| British journal of anaesthesia | 2 |
Showing 5 of 26 journals.
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 |
|---|---|---|
| 26 | 9 | 2025-12-30 |
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 | 719,887,000 | 98,094,000 | 85,844,000 |
| 2024 | 731,967,000 | 159,519,000 | 73,914,000 |
| 2023 | 644,395,000 | 137,545,000 | 73,741,000 |
| 2022 | 498,987,000 | 91,386,000 | 74,771,000 |
| 2021 | 437,768,000 | 62,116,000 | 60,932,000 |
| 2020 | 349,846,000 | 1,403,000 | 67,229,000 |
| 2019 | 322,357,000 | 48,939,000 | 68,853,000 |
| 2018 | 294,666,000 | -5,738,000 | 57,564,000 |
| 2017 | 240,175,000 | 3,647,000 | 43,503,000 |
| 2016 | 255,165,000 | 9,820,000 | 41,522,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (22)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-03-03 | Other financing | not disclosed | Sec extracted |
| 2026-01-06 | Royalty / licensing | 2,000,000 | Sec extracted |
| 2026-01-06 | Royalty / licensing | not disclosed | Sec extracted |
| 2026-01-06 | Royalty / licensing | not disclosed | Sec extracted |
| 2025-10-21 | Royalty / licensing | not disclosed | Sec extracted |
Showing 5 of 22 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 13 |
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00 | Class II | 2017-08-15 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 2 | 2012-11-23 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | Rancho Cucamonga, 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 |
Latest dated events (108)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-07-02 | FDA warning letter | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-04-06 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-04-01 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-03-03 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-01-06 | Royalty / licensing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
Showing 5 of 108 events.
Biomarker capability evidence (16)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| APOH | Trial sponsor | Named in trial inclusion criteria |
| APOH | Trial sponsor | Named in trial inclusion criteria |
| APOH | Trial sponsor | Named in trial inclusion criteria |
| APOH | Trial sponsor | Named in trial inclusion criteria |
| PSMB7 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 16 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: related companies not grouped here, active development programs, fda warning letters, fda untitled letters, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.