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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 Receives FDA Tentative Approval for Generic Asthma Inhaler, Targeting $329M Market

Amneal Pharmaceuticals received FDA tentative approval for beclomethasone dipropionate HFA inhalation aerosol, a generic version of Teva's QVAR asthma treatment.

Amneal Launches Brekiya, First Self-Administered DHE Autoinjector for Migraine and Cluster Headaches

Amneal Pharmaceuticals has commercially launched Brekiya, the first and only self-administered dihydroergotamine autoinjector approved for acute treatment of migraine and cluster headaches in adults.

Amneal Submits BLA for Omalizumab Biosimilar to Challenge $4.1 Billion XOLAIR Market

Amneal Pharmaceuticals has submitted a Biologics License Application to the FDA for a biosimilar to XOLAIR (omalizumab), developed in partnership with Kashiv BioSciences.

Apiject Submits First-of-Kind Prefilled Plastic Injection Device to FDA for Approval

Apiject Systems has submitted a New Drug Application to the FDA for the world's first injectable medicine using its single-dose, single-use prefilled plastic syringe containing glycopyrrolate.

Amneal Pharmaceuticals Receives FDA Approval for Generic Bimatoprost Eye Drops to Treat Glaucoma

Amneal Pharmaceuticals received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, a prostaglandin analog used to reduce elevated intraocular pressure in glaucoma patients.

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.

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