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Amneal Pharmaceuticals

Amneal Pharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
1995-01-01
Employees
7.7K
Market Cap
$2.6B
Website
http://www.amneal.com

Clinical Trials

21

Active:2
Completed:15

Trial Phases

4 Phases

Phase 1:6
Phase 2:2
Phase 3:11
+1 more phases

Drug Approvals

5

FDA:5

Drug Approvals

ZOMIG

Approval Date
May 31, 2019
FDA

Zolmitriptan

Approval Date
May 31, 2019
FDA

ZOMIG

Approval Date
May 31, 2019
FDA

Potassium Chloride

Approval Date
Feb 25, 2013
FDA

Metformin Hydrochloride

Approval Date
Sep 6, 2012
FDA

Clinical Trials

Distribution across different clinical trial phases (20 trials with phase data)• Click on a phase to view related trials

Phase 3
11 (55.0%)
Phase 1
6 (30.0%)
Phase 2
2 (10.0%)
Not Applicable
1 (5.0%)

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

Phase 1
Recruiting
Conditions
Open-angle Glaucoma
Ocular 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

and more 1 locations

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.

Phase 3
Conditions
Glaucoma, Open-Angle
Ocular 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

and more 6 locations

BE Study in Patients - Methotrexate Tablets

Phase 1
Conditions
Psoriasis
Rheumatoid 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

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
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

and more 7 locations

Study Comparing a Generic Diclofenac Sodium Topical Gel, 1% to Voltaren in the Treatment of Subjects With Osteoarthritis of the Knee

Phase 3
Completed
Conditions
Osteoarthritis
Interventions
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

and more 19 locations
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News

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.

Federal Circuit Rules Against Teva's Orange Book Patent Listings for ProAir HFA Inhaler

The U.S. District Court ordered Teva Pharmaceuticals to remove its ProAir HFA inhaler device patents from the FDA's Orange Book, ruling they don't meet statutory listing requirements.

Amneal Pharmaceuticals Reports 18% Revenue Growth, Expands into Weight Loss and Biosimilar Markets

Amneal Pharmaceuticals achieved Q4 2023 revenues of $730.52 million, marking an 18% year-over-year growth driven by strong performance across Affordable Medicines, AvKARE, and Specialty segments.

Bevacizumab Biosimilars Demonstrate Comparable Efficacy and Safety Profile to Avastin in Advanced NSCLC Study

A comprehensive study of 1,058 NSCLC patients reveals bevacizumab biosimilars match the reference drug Avastin in overall response rates, with biosimilars achieving 27.41% compared to 29.79% for the original drug.

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