Amphastar Pharmaceuticals
- Country
- 🇺🇸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.
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
- First Posted Date
- 2022-09-14
- Last Posted Date
- 2024-01-29
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 69
- Registration Number
- NCT05539872
- Locations
- 🇺🇸
Amphastar Study Site, Chula Vista, California, United States
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
- Conditions
- AlbuterolAsthmaPharmacokineticsEpinephrineAnaphylaxis
- Interventions
- Combination Product: Epinephrine (0.125 mg/inhalation)Combination Product: Epinephrine Injection Auto-Injector (0.3mg/0.3mL)Combination Product: Albuterol Sulfate (0.09 mg/inhalation)
- First Posted Date
- 2019-12-23
- Last Posted Date
- 2021-03-30
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 28
- Registration Number
- NCT04207840
- Locations
- 🇺🇸
Amphastar Study Site 0035, Cypress, California, United States
Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers
- First Posted Date
- 2014-10-22
- Last Posted Date
- 2017-04-19
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT02271334
- Locations
- 🇺🇸
Amphastar Site 0035, Cypress, California, United States
Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation
- First Posted Date
- 2014-08-07
- Last Posted Date
- 2017-04-19
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT02210806
- Locations
- 🇺🇸
Amphastar Site 0030, New Braunfels, Texas, United States
🇺🇸Amphastar Site 0025, Medford, Oregon, United States
🇺🇸Amphastar Site 0001, San Jose, California, United States
Evaluation of Efficacy and Safety for Single Dose of E004 in Children With Asthma
- First Posted Date
- 2012-11-30
- Last Posted Date
- 2016-03-11
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 28
- Registration Number
- NCT01737905
- Locations
- 🇺🇸
The Clinical Research Institute of Southern Oregn, PC, Medford, Oregon, United States
🇺🇸West Coast Clinical Trials Global, Cypress, California, United States
🇺🇸Western Sky Medical, El Paso, Texas, United States
Assessment and Evaluation of Pharmacokinetic Profile of E004 in Healthy Adults
- Conditions
- Asthma
- Interventions
- Drug: Arm C-Epinephrine Inhalation Aerosol CFC
- First Posted Date
- 2012-11-30
- Last Posted Date
- 2016-03-17
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 21
- Registration Number
- NCT01737892
- Locations
- 🇺🇸
West Coast Clinical Trials, LLC, Cypress, California, United States
Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP)
- Conditions
- Allergic Skin Reaction
- Interventions
- First Posted Date
- 2012-09-21
- Last Posted Date
- 2017-01-20
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 253
- Registration Number
- NCT01689363
- Locations
- 🇺🇸
Amphastar Site 0026, Portland, Oregon, United States
🇺🇸Amphastar Site 0038, Renton, Washington, United States
🇺🇸Amphastar Site 0022, Eugene, Oregon, United States
Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2012-04-20
- Last Posted Date
- 2017-05-19
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 23
- Registration Number
- NCT01581177
- Locations
- 🇺🇸
Amphastar Site 0032, San Antonio, Texas, United States
🇺🇸Amphastar Site 0001, San Jose, California, United States
🇺🇸Amphastar Site 0025, Medford, Oregon, United States
Safety Study in Adolescent and Adult Patients With Asthma
- Conditions
- Asthma
- Interventions
- First Posted Date
- 2011-11-22
- Last Posted Date
- 2017-02-13
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 208
- Registration Number
- NCT01476904
- Locations
- 🇺🇸
Amphastar Site 0006, Costa Mesa, California, United States
🇺🇸Amphastar Site 0004, Orange, California, United States
🇺🇸Amphastar Site 0008, Denver, Colorado, United States
Evaluation of Efficacy and Safety of E004 in Children With Asthma
- Conditions
- Asthma
- Interventions
- Drug: E004 (Epinephrine Inhalation Aerosol) HFA-MDIDrug: Placebo-HFA
- First Posted Date
- 2011-10-27
- Last Posted Date
- 2018-07-31
- Lead Sponsor
- Amphastar Pharmaceuticals, Inc.
- Target Recruit Count
- 70
- Registration Number
- NCT01460511
- Locations
- 🇺🇸
Amphastar Site 6, San Antonio, Texas, United States
🇺🇸Amphastar Site 7, North Charleston, South Carolina, United States
🇺🇸Amphastar Site 8, Orange, California, United States