Amneal Pharmaceuticals
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 1995-01-01
- Employees
- 7.7K
- Market Cap
- $2.6B
- Website
- http://www.amneal.com
Clinical Trials
21
Trial Phases
4 Phases
Drug Approvals
5
Drug Approvals
Clinical Trials
Distribution across different clinical trial phases (20 trials with phase data)• Click on a phase to view related trials
A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes
- Conditions
- Open-angle GlaucomaOcular Hypertension
- Interventions
- First Posted Date
- 2024-02-20
- Last Posted Date
- 2024-08-06
- Lead Sponsor
- Amneal Pharmaceuticals, LLC
- Target Recruit Count
- 240
- Registration Number
- NCT06267274
- Locations
- 🇺🇸
West Coast Eye Institute, Bakersfield, California, United States
🇺🇸Eye Research Foundation, Newport Beach, California, United States
🇺🇸Clayton Eye Research, Morrow, Georgia, United States
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.
- Conditions
- Glaucoma, Open-AngleOcular Hypertension
- Interventions
- Drug: Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)Drug: Test - Bimatoprost 0.01% Ophthalmic Solution
- First Posted Date
- 2022-06-02
- Last Posted Date
- 2022-08-10
- Lead Sponsor
- Amneal Pharmaceuticals, LLC
- Target Recruit Count
- 168
- Registration Number
- NCT05401357
- Locations
- 🇺🇸
Eye Research Foundation Inc., Newport Beach, California, United States
🇺🇸North Bay Eye Associates, Inc., Petaluma, California, United States
🇺🇸Volusia Eye Associates, New Smyrna Beach, Florida, United States
BE Study in Patients - Methotrexate Tablets
- Conditions
- PsoriasisRheumatoid Arthritis
- Interventions
- First Posted Date
- 2016-10-21
- Last Posted Date
- 2016-10-21
- Lead Sponsor
- Amneal Pharmaceuticals, LLC
- Target Recruit Count
- 48
- Registration Number
- NCT02940561
- Locations
- 🇮🇳
Saviour Hospital, Ahmedabad, Gujarat, India
🇮🇳Sterling Hospital, Ahmedabad, Gujarat, India
🇮🇳Kanoria Hospital, Gandhinagar, Gujurat, India
Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: Placebo Nasal Spray
- First Posted Date
- 2014-04-29
- Last Posted Date
- 2015-11-01
- Lead Sponsor
- Amneal Pharmaceuticals, LLC
- Target Recruit Count
- 811
- Registration Number
- NCT02125253
- Locations
- 🇺🇸
Isis Clinical Research, Austin, Texas, United States
🇺🇸Austin Clinical Research, Austin, Texas, United States
🇺🇸Sirius Clinical Research, Austin, Texas, United States
Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee
- Conditions
- Osteoarthritis
- Interventions
- Drug: Vehicle Diclofenac Sodium Topical Gel
- First Posted Date
- 2014-04-23
- Last Posted Date
- 2021-06-16
- Lead Sponsor
- Amneal Pharmaceuticals, LLC
- Target Recruit Count
- 1176
- Registration Number
- NCT02121002
- Locations
- 🇮🇳
Sunshine Hospitals, Secunderabad, Andhra Pradesh, India
🇮🇳King George Hospital, Visakhapatnam, Andra Pradesh, India
🇮🇳Rathi Orthopedic and Research Centre, Ahmedabad, Gujarat, India
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News
Amneal Receives FDA Approval for Generic Sodium Oxybate, Breaking Jazz Pharmaceuticals' Monopoly in Narcolepsy Treatment
Amneal Pharmaceuticals received FDA approval for its generic sodium oxybate oral solution 500 mg/mL, referencing Jazz Pharmaceuticals' Xyrem for narcolepsy treatment.
FDA Issues Warning to Amneal Pharmaceuticals Over Contaminated IV Bags in Sterile Injectable Production
The FDA issued a warning to Amneal Pharmaceuticals after discovering the company used contaminated intravenous bags in sterile injectable drug production.
Knight Therapeutics Files New Drug Submission for CREXONT in Canada Following Successful Phase 3 Trial
Knight Therapeutics has filed a New Drug Submission for CREXONT, a novel extended-release carbidopa/levodopa formulation for Parkinson's disease, which has been accepted for review by Health Canada.
Amneal Secures FDA Approval for Generic Prednisolone Acetate Eye Drops, Targeting $201 Million Market
Amneal Pharmaceuticals received FDA approval for prednisolone acetate ophthalmic suspension 1%, a generic version of Allergan's Pred Forte for treating steroid-responsive ocular inflammation.
Amneal Pharmaceuticals Reports Strong Q1 2025 Results with 5% Revenue Growth and Margin Expansion
Amneal Pharmaceuticals reported Q1 2025 revenue of $695 million, a 5% year-over-year increase, with growth across all three business segments despite falling short of analyst expectations.
FDA Approves Brekiya: First DHE Autoinjector for Acute Migraine and Cluster Headache Treatment
The FDA has approved Amneal Pharmaceuticals' Brekiya, the first and only dihydroergotamine (DHE) autoinjector for acute treatment of migraine and cluster headaches in adults.
Amneal and Apiject Partner to Expand US-Based Sterile Injectable Manufacturing with Advanced BFS Technology
Amneal Pharmaceuticals and Apiject Systems have formed a strategic collaboration to expand domestic production of sterile drug dosage forms using Blow-Fill-Seal technology at Amneal's Brookhaven, NY facility.
Jazz and Hikma to Pay $195M to Settle Antitrust Claims Over Narcolepsy Drug Xyrem
Jazz Pharmaceuticals will pay $145 million to settle allegations of anti-competitive practices related to its narcolepsy drug Xyrem, while denying all wrongdoing in the class action lawsuit.
Amneal's CREXONT Shows Significant Sleep Quality Improvements in Parkinson's Disease Patients
New Phase 3 RISE-PD study data reveals CREXONT (carbidopa/levodopa extended-release) significantly improved sleep quality in Parkinson's disease patients compared to immediate-release formulations, with a mean difference of -2.35 in PDSS-2 scores (p<0.0001).
Amneal Launches Boruzu: First Ready-to-Use Bortezomib Injection for Multiple Myeloma Treatment
Amneal Pharmaceuticals and Shilpa Medicare have launched Boruzu, the first ready-to-use bortezomib formulation for subcutaneous or intravenous administration in multiple myeloma and mantle cell lymphoma treatment.