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.
Clinical Trials
20
Trial Phases
4 Phases
Drug Approvals
11
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (20 trials with phase data)• Click on a phase to view related trials
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
- 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 0001, San Jose, California, United States
🇺🇸Amphastar Site 0025, Medford, Oregon, United States
🇺🇸Amphastar Site 0030, New Braunfels, Texas, 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
- 🇺🇸
West Coast Clinical Trials Global, Cypress, California, United States
🇺🇸The Clinical Research Institute of Southern Oregn, PC, Medford, Oregon, United States
🇺🇸Transitional Clinical Research, Inc. Allergy Associates Research Center, Portland, Oregon, United States
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News
Amphastar Pharmaceuticals Plans to Quadruple US Manufacturing Capacity in Major Domestic Expansion
Amphastar Pharmaceuticals announced a multi-year expansion to quadruple production capacity at its Rancho Cucamonga headquarters over the next three to five years.
FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings
The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book.