Company profile
Amphastar Pharmaceuticals, Inc.
NASDAQ:AMPHBiotechnology: Pharmaceutical Preparations
Drug pipeline (15)
| Asset | Stage | Revenue | Trials | Status |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | approved | — | 0 | — |
| COSYNTROPIN | approved | — | 0 | — |
| ENOXAPARIN SODIUM | approved | — | 6 | approved |
| GANIRELIX ACETATE | approved | — | 0 | — |
| Glucagon | approved | — | 7 | approved |
Revenue is the latest reported period from SEC filings. A combination product's amount appears on each of its constituent assets, so those rows are not additive.
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 | Type | Applicant | Products | |||
|---|---|---|---|---|---|---|
| ANDA 076209 | ANDA | AMPHASTAR PHARMACEUTICAL INC | ||||
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| ANDA 076684 | ANDA | AMPHASTAR PHARMACEUTICAL INC | ||||
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| ANDA 077235 | ANDA | AMPHASTAR PHARMACEUTICALS INC | ||||
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| ANDA 077334 | ANDA | AMPHASTAR PHARMACEUTICALS INC | ||||
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| ANDA 208086 | ANDA | AMPHASTAR PHARMACEUTICALS INC | ||||
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