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Amphastar Pharmaceuticals, Inc. (AMPH)

Amphastar Pharmaceuticals, Inc., established in 1996 and based in Rancho Cucamonga, California, functions as a biopharmaceutical enterprise. The company is engaged in the creation, production, commercialization, and distribution of both generic and proprietary pharmaceutical products, which include injectables, inhalants, and intranasal formulations. Its market presence extends across the United States, China, and France. Amphastar's operations are divided into two primary segments: Finished Pharmaceutical Products and Active Pharmaceutical Ingredients (API). The company's extensive product portfolio encompasses a variety of crucial medications. These feature Primatene Mist, an over-the-counter epinephrine inhaler for the temporary alleviation of mild asthma symptoms; Enoxaparin, a low molecular weight heparin utilized for the prevention and treatment of deep vein thrombosis; and Naloxone, an essential treatment for opioid overdose. Other significant offerings include emergency Glucagon injection kits; Cortrosyn, a diagnostic agent for adrenocortical insufficiency; and Amphadase, a bovine-sourced hyaluronidase injection that aids in the absorption and dispersion of other administered drugs. Amphastar additionally supplies Epinephrine injections for severe allergic reactions; various lidocaine products (such as a jelly for urological procedures and a topical solution for other applications); Phytonadione injection (Vitamin K1) for newborns; and specialized emergency syringe products for hospital use. Furthermore, the company provides Morphine injections for patient-controlled analgesia and Lorazepam injections for surgical and medical procedures. More advanced therapeutics consist of Neostigmine methylsulfate injection to manage myasthenia gravis and reverse muscle relaxant effects, and Isoproterenol hydrochloride injection for mild or transient episodes of heart block. Beyond its finished pharmaceutical goods, Amphastar also acts as a distributor for recombinant human insulin API and porcine insulin API. The company caters to a broad spectrum of healthcare providers, including hospitals, various care facilities, clinics, and physicians' offices.

Sector: Pharmaceutical Preparations

Industry: Drug Manufacturers - Specialty & Generic

Amphastar Pharmaceuticals, Inc. logo

Amphastar Pharmaceuticals, Inc.

NASDAQ:AMPHHealthcare
+2.93%$27.72
AH$27.72+0.00%vs close
Mkt Cap$1.18B
Float29.13M
O/S42.54M
Vol
$ Vol
RVOL
Inst Own66.6%
SI14.9%
Earnings
Dilution
Amphastar Pharmaceuticals, Inc. logoNASDAQ:AMPH$27.72+2.93%
Phase Distribution
21 lead-sponsored trials·0 active·16 completed
Phase 1/24
Phase 27
Phase 2/32
Phase 37
Phase 41
Status Overview
Completed16
Stopped5

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 4
    Completed

    Study of Drug Exposure in Systemic Circulation of Primatene Mist by Oral Inhalation, Versus Epinephrine Injection by Intramuscular Injection and ProAir by Oral Inhalation in Healthy Individuals

    Epinephrine (0.125 mg/inhalation), Epinephrine Injection Auto-Injector (0.3mg/0.3mL)

    Pharmacokinetics, Epinephrine +3

    Enrollment
    28
    Start
    Dec 2019
    Primary Completion
    Dec 2019
    Completion
    Dec 2019
    NCT04207840
  • Phase 3
    Terminated

    4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma

    Armstrong Albuterol Sulfate Inhalation Aerosol, Albuterol Sulfate Inhalation Aerosol

    Asthma

    Enrollment
    48
    Start
    Mar 2008
    Primary Completion
    Dec 2008
    Completion
    Dec 2008
    NCT00634517
  • Phase 3
    Terminated

    Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction

    albuterol (Armstrong Albuterol HFA), Albuterol Sulfate (Provenetil-HFA)

    Asthma, Bronchospasm

    Enrollment
    24
    Start
    Feb 2008
    Primary Completion
    Oct 2008
    Completion
    Oct 2008
    NCT00634829
  • Phase 3
    Terminated

    Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients

    albuterol HFA (Armstrong's), albuterol HFA (Proventil HFA)

    Asthma

    Enrollment
    300
    Start
    Sep 2007
    Primary Completion
    Aug 2008
    Completion
    Aug 2008
    NCT00635505
  • Phase 3
    Completed

    Epinephrine Inhalation Aerosol USP: For Evaluation Of Efficacy And Safety In Asthma Patients

    Epinephrine inhalation aerosol, Placebo

    Asthma

    Enrollment
    373
    Start
    Jul 2011
    Primary Completion
    Nov 2011
    Completion
    Dec 2011
    NCT01357642
  • Phase 3
    Completed

    Evaluation of Efficacy and Safety of E004 in Children With Asthma

    E004 (Epinephrine Inhalation Aerosol) HFA-MDI, Placebo-HFA

    Asthma

    Enrollment
    70
    Start
    Oct 2011
    Primary Completion
    Mar 2012
    Completion
    Jul 2012
    NCT01460511
  • Phase 3
    Completed

    Safety Study in Adolescent and Adult Patients With Asthma

    Placebo, Primatene Mist

    Asthma

    Enrollment
    208
    Start
    Nov 2011
    Primary Completion
    Apr 2012
    Completion
    Jul 2012
    NCT01476904
  • Phase 3
    Completed

    Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma

    Epinephrine HFA-MDI (E004), Placebo-HFA

    Asthma

    Enrollment
    28
    Start
    Oct 2012
    Primary Completion
    Mar 2013
    Completion
    Dec 2013
    NCT01737905
  • Phase 2/3
    Completed

    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

    I004, NovoLog

    Pharmacokinetics, Pharmacodynamics

    Enrollment
    69
    Start
    Aug 2022
    Primary Completion
    Jan 2023
    Completion
    Jan 2023
    NCT05539872
  • Phase 2/3
    Completed

    Comparison of the Pharmacokinetics (PK) and Pharmacodynamics (PD) Biosimilarity of Proposed Biosimilar/Interchangeable Rapid-Acting Insulin Aspart (I004) and NovoLog® After Single-Dose Subcutaneous Administration to Healthy Volunteers

    I004, NovoLog

    Pharmacokinetics, Pharmacodynamics +1

    Enrollment
    62
    Start
    Apr 2026
    Primary Completion
    Jun 2026
    Completion
    Jun 2026
    NCT07560150
  • Phase 2
    Completed

    Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

    albuterol inhalation powder, albuterol inhalation powder

    Asthma, Bronchospasm

    Enrollment
    26
    Start
    Jul 2010
    Primary Completion
    Oct 2010
    Completion
    Jan 2011
    NCT01174732
  • Phase 2
    Completed

    Escalating and Cumulative-Dose Study of Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety of A006

    A006, Placebo DPI

    Asthma, Bronchospasm +1

    Enrollment
    27
    Start
    Jul 2010
    Primary Completion
    Dec 2010
    Completion
    Jan 2011
    NCT01189396
  • Phase 2
    Completed

    Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS

    Arm T1: Primatene Mist HFA, Arm T2: Primatene Mist HFA

    Asthma

    Enrollment
    24
    Start
    Dec 2010
    Primary Completion
    Jan 2011
    Completion
    Jan 2011
    NCT01255709
  • Phase 2
    Completed

    Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

    Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh

    Asthma

    Enrollment
    23
    Start
    Apr 2012
    Primary Completion
    Jul 2012
    Completion
    Aug 2012
    NCT01581177
  • Phase 2
    Completed

    Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)

    Hyaluronidase, Histamine

    Allergic Skin Reaction

    Enrollment
    253
    Start
    Sep 2012
    Primary Completion
    Nov 2012
    Completion
    Dec 2012
    NCT01689363
  • Phase 2
    Completed

    Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation

    A006 DPI, A006 DPI

    Asthma

    Enrollment
    22
    Start
    Jul 2014
    Primary Completion
    Sep 2014
    Completion
    Oct 2014
    NCT02210806
  • Phase 2
    Completed

    Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

    A006 DPI, A006 DPI

    Asthma

    Enrollment
    22
    Start
    Aug 2014
    Primary Completion
    Oct 2014
    Completion
    Mar 2015
    NCT02271334
  • Phase 1/2
    Terminated

    Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.

    E004 (epinephrine inhalation aerosol), 90 mcg/actuation, E004 Placebo

    Asthma

    Enrollment
    9
    Start
    Dec 2009
    Primary Completion
    Dec 2009
    Completion
    Dec 2009
    NCT01025648
  • Phase 1/2
    Completed

    Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers

    epinephrine inhalation aerosol, epinephrine inhalation aerosol

    Asthma

    Enrollment
    24
    Start
    Jan 2010
    Primary Completion
    Jun 2010
    Completion
    Jun 2010
    NCT01143051
  • Phase 1/2
    Completed

    Epinephrine Inhalation Aerosol USP, a HFA-MDI Study for Assessment of Pharmacokinetics

    Epinephrine Inhalation Aerosol, HFA, Epinephrine Inhalation Aerosol

    Asthma, Bronchospasm +2

    Enrollment
    23
    Start
    Aug 2010
    Primary Completion
    Sep 2010
    Completion
    Jan 2011
    NCT01188577
  • Phase 1/2
    Terminated

    Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults

    Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation, Arm C-Epinephrine Inhalation Aerosol CFC

    Asthma

    Enrollment
    21
    Start
    Nov 2012
    Primary Completion
    Nov 2012
    Completion
    Nov 2012
    NCT01737892
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