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
21
0 active
Approvals
26
Total approvals
Agencies
3
Regulatory bodies
Founded
1996
Completed
16
76.2%
Terminated
5
23.8%
- The FDA approved Rextovy, a new 4 mg over-the-counter naloxone hydrochloride nasal spray from Amphastar Pharmaceuticals, for emergency opioid overdose reversal. - This approval broadens consumer access, allowing purchase without a prescription at pharmacies, convenience stores, and online marketplaces. - U.S. overdose deaths dropped from 111,451 (12 months ending August 2023) to 68,632 (12 months ending December 2025), coinciding with expanded OTC naloxone availability. - The FDA emphasizes that multiple OTC naloxone options drive market competition, potentially lowering retail costs and increasing community distribution.
- Amphastar is transitioning from generic drugs to proprietary therapies with four new chemical entities (NCEs) showing promising preclinical and early clinical data. - AMP-107 represents a potential breakthrough as the first non-injectable anti-VEGFR eye drop, targeting a $9.4 billion market for wet AMD and diabetic macular edema. - The company's oncology candidate AMP-105 demonstrates a novel mechanism targeting cell growth and metastasis inhibition with broader anti-tumor activity. - Near-term launches include AMP-007 metered-dose inhaler expected mid-2026 and AMP-004 insulin aspart projected for 2027.
- Amphastar Pharmaceuticals has entered into an exclusive licensing agreement with Nanjing Hanxin Pharmaceutical for AMP-110, a fully synthetic human adrenocorticotropic hormone analog targeting inflammatory and autoimmune conditions. - The deal includes $2 million upfront, up to $89 million in milestone payments, and up to $60 million in royalties, providing Amphastar exclusive rights in the US and Canada markets. - AMP-110 is currently in early-phase clinical development with promising safety data and targets a US ACTH market exceeding $684 million annually in 2024. - The synthetic compound is designed to offer improved safety compared to existing porcine-derived ACTH products for conditions including multiple sclerosis, rheumatoid arthritis, and infantile spasms.
- CorMedix announced interim results from an ongoing real-world evidence study showing DefenCath achieved a 72% reduction in catheter-related bloodstream infections and 70% reduction in related hospitalizations compared to historical controls. - The study analyzed approximately 7,000 patients receiving DefenCath through September 2025, with over 3,000 patients per month currently receiving the treatment at U.S. Renal Care facilities. - DefenCath represents significant cost savings potential, as CMS spends over $3 billion annually on CRBSI-related costs in ESRD patients, with each hospitalization costing approximately $63,000 to $110,000. - The company reported preliminary Q4 2025 revenues of approximately $127 million and expects 2026 DefenCath revenues of $150-170 million, though growth faces competitive pressure from established heparin manufacturers.
- Amphastar Pharmaceuticals received FDA approval for its generic teriparatide injection, marking the company's first pen device combination product and providing a bioequivalent alternative to Eli Lilly's FORTEO. - The approved product targets a substantial $585 million U.S. market for teriparatide injection and is indicated for treating osteoporosis in high-risk patients across multiple populations. - Amphastar plans to launch the product by year-end, leveraging domestic manufacturing capabilities to offer an affordable treatment option for daily osteoporosis therapy.
- Amphastar Pharmaceuticals has entered into an exclusive licensing agreement with Nanjing Anji Biotechnology for three proprietary peptide therapeutics targeting oncology and ophthalmology indications in the US and Canada. - The deal includes an endogenous peptide for cancer growth suppression, a peptide-docetaxel conjugate designed to reduce toxicity, and an anti-VEGFR peptide eye drop for wet age-related macular degeneration. - The agreement involves $6 million in upfront payments and potential milestone payments totaling up to $453 million, with 5% royalties on net sales capped at $60 million per product. - The licensing terms extend for ten years from first commercial sale with potential extension for an additional decade, strengthening Amphastar's proprietary peptide pipeline.
- Amphastar Pharmaceuticals received FDA approval for its generic iron sucrose injection (AMP-002) in three dosage strengths for treating iron deficiency anemia in chronic kidney disease patients. - The FDA determined that Amphastar's iron sucrose injection meets bioequivalence and therapeutic equivalence criteria to the reference drug Venofer®, which generated approximately $513 million in U.S. sales over the past 12 months. - The company plans to launch the generic iron sucrose injection in the third quarter of 2025, adding to its pipeline of complex generic and biosimilar products targeting markets worth over $9.5 billion combined.
- Amphastar Pharmaceuticals announced a multi-year expansion to quadruple production capacity at its Rancho Cucamonga headquarters over the next three to five years. - The strategic initiative represents the company's largest domestic infrastructure investment, featuring a new state-of-the-art production plant with expanded automation and advanced technologies. - The expansion will support development and manufacture of critical medications including new pipeline candidates, while creating jobs in R&D, engineering, manufacturing, and quality operations. - All of Amphastar's finished pharmaceutical products are manufactured in the United States, reinforcing the company's commitment to domestic production and supply chain resilience.
- 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. - The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications. - According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.
