Company profile
AMPHASTAR PHARMACEUTICALS, INC.
NASDAQ:AMPHBiotechnology: Pharmaceutical Preparations
Drug pipeline (18)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| BAQSIMI | approved | $0.1MQ2 2026 | 7 | approved |
| AMPHADASE | approved | — | 0 | — |
| CORTROSYN | approved | — | 0 | — |
| DUOCAINE | approved | — | 0 | — |
| ENOXAPARIN SODIUM | approved | — | 13 | 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 (20)
| NCT ID | Phase | Status | Start | Completion | Sponsor name | Title |
|---|---|---|---|---|---|---|
| NCT00634517 | phase3 | terminated | 2008-03-01 | 2008-12-01 | Amphastar Pharmaceuticals, Inc. | 4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma |
| NCT01581177 | phase2 | completed | 2012-04-01 | 2012-07-01 | Amphastar Pharmaceuticals, Inc. | Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation |
| NCT02210806 | phase2 | completed | 2014-07-01 | 2014-09-01 | Amphastar Pharmaceuticals, Inc. | Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation |
| NCT01737892 | phase1_2 | terminated | 2012-11-01 | 2012-11-01 | Amphastar Pharmaceuticals, Inc. | Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults |
| NCT05539872 | phase2_3 | completed | 2022-08-22 | 2023-01-29 | Amphastar Pharmaceuticals, Inc. | Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar Rapid-Acting Insulin Aspart (I004) and NovoLog After Single-Dose Subcutaneous Administration to Healthy Volunteers |
FDA applications (18)
| Application | Approved | Type | Applicant | Products | ||||
|---|---|---|---|---|---|---|---|---|
| ANDA 213641 | 2025-12-12 | ANDA | AMPHASTAR PHARMACEUTICALS INC | |||||
Loading… | ||||||||
| NDA 208969 | 2023-03-07 | NDA | AMPHASTAR PHARMACEUTICALS INC | |||||
Loading… | ||||||||
| ANDA 211857 | 2022-07-18 | ANDA | AMPHASTAR PHARMACEUTICALS INC | |||||
Loading… | ||||||||
| ANDA 212613 | 2022-04-07 | ANDA | AMPHASTAR PHARMACEUTICALS INC | |||||
Loading… | ||||||||
| ANDA 208086 | 2020-12-28 | ANDA | AMPHASTAR PHARMACEUTICALS INC | |||||
Loading… | ||||||||