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Amphastar Pharmaceuticals

Amphastar Pharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
1996-01-01
Employees
1.7K
Market Cap
$2.3B
Website
http://www.amphastar.com
Introduction

Amphastar Pharmaceuticals, Inc. engages in developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, and insulin active pharmaceutical ingredient. It operates through Finished Pharmaceutical Products and Active Pharmaceutical Ingredients Products segments. The Finished Pharmaceutical Products segment manufactures, markets, and distributes Primatene Mist, enoxaparin, naloxone, phytonadione, lidocaine, and other critical and non-critical care drugs. The Active Pharmaceutical Ingredients Products segment offers RHI API and porcine insulin API for external customers and internal product development. The company was founded by Zi-Ping Luo and Yong Feng Zhang on February 29, 1996 and is headquartered in Rancho Cucamonga, CA.

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

Phase 3
Completed
Conditions
Asthma
Interventions
First Posted Date
2011-05-23
Last Posted Date
2016-03-11
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
373
Registration Number
NCT01357642
Locations
🇺🇸

West Coast Clinical Trials, Costa Mesa, California, United States

🇺🇸

Southern California Institute for Respiratory Diseases, Los Angeles, California, United States

🇺🇸

Asthma and Allergy Associates of Southern California, Mission Viejo, California, United States

and more 28 locations

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

Phase 2
Completed
Conditions
Asthma
First Posted Date
2010-12-07
Last Posted Date
2016-03-17
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT01255709
Locations
🇺🇸

Amphastar Study Site 1, Cypress, California, United States

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

Phase 2
Completed
Conditions
Asthma
Bronchospasm
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
Drug: Proventil-HFA
Drug: Placebo DPI
First Posted Date
2010-08-26
Last Posted Date
2017-07-02
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT01189396
Locations
🇺🇸

Amphastar Site 0026, Portland, Oregon, United States

🇺🇸

Amphastar Site 0025, Medford, Oregon, United States

🇺🇸

Amphastar Site 0032, San Antonio, Texas, United States

and more 1 locations

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

Phase 1
Completed
Conditions
Asthma
Bronchospasm
Wheezing
Shortness of Breath
Interventions
First Posted Date
2010-08-25
Last Posted Date
2017-07-25
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
23
Registration Number
NCT01188577
Locations
🇺🇸

Amphastar Site 0035, Cypress, California, United States

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

Phase 2
Completed
Conditions
Bronchospasm
Asthma
Interventions
First Posted Date
2010-08-04
Last Posted Date
2017-04-19
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
26
Registration Number
NCT01174732
Locations
🇺🇸

Amphastar Site 0039, Lakewood, Colorado, United States

🇺🇸

Amphastar Site 0001, San Jose, California, United States

🇺🇸

Amphastar Site 0008, Denver, Colorado, United States

and more 1 locations

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

Phase 1
Completed
Conditions
Asthma
Interventions
First Posted Date
2010-06-14
Last Posted Date
2018-09-25
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT01143051
Locations
🇺🇸

Amphastar Location 1, Cypress, California, United States

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

Phase 1
Terminated
Conditions
Asthma
Interventions
Drug: E004 (epinephrine inhalation aerosol), 220 mcg
Drug: E004 (epinephrine inhalation aerosol), 90 mcg/actuation
Drug: E004 (epinephrine inhalation aerosol), 125 mcg
Drug: E004 (epinephrine inhalation aerosol), 160 mcg
Drug: E004 Placebo
First Posted Date
2009-12-03
Last Posted Date
2018-05-16
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
9
Registration Number
NCT01025648
Locations
🇺🇸

Amphastar Site 0003, Stockton, California, United States

🇺🇸

Amphastar Site 0001, San Jose, California, United States

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

Phase 3
Terminated
Conditions
Asthma
Bronchospasm
Interventions
First Posted Date
2008-03-13
Last Posted Date
2013-07-15
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
24
Registration Number
NCT00634829
Locations
🇺🇸

Colorado Allergy and Asthma Center, Lakewood, Colorado, United States

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

Phase 3
Terminated
Conditions
Asthma
Interventions
First Posted Date
2008-03-13
Last Posted Date
2013-07-15
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
300
Registration Number
NCT00635505
Locations
🇺🇸

Pulmonary Associates of Mobile, PC, Mobile, Alabama, United States

🇺🇸

MEDEX Healthcare Research, Inc., St. Louis, Missouri, United States

🇺🇸

The Clinical Research Center, LLC, St. Louis, Missouri, United States

and more 38 locations

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

Phase 3
Terminated
Conditions
Asthma
Interventions
Drug: Armstrong Albuterol Sulfate Inhalation Aerosol
First Posted Date
2008-03-13
Last Posted Date
2013-07-15
Lead Sponsor
Amphastar Pharmaceuticals, Inc.
Target Recruit Count
48
Registration Number
NCT00634517
Locations
🇺🇸

Integrated Medical Research, Ashland, Oregon, United States

🇺🇸

Allergy Associates Research Center, Portland, Oregon, United States

🇺🇸

Allergy Associates Medical Group, Inc., San Diego, California, United States

and more 5 locations
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