MedPath

McGuff Pharmaceuticals, Inc.

🇺🇸United States
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

1

Active:0
Completed:1

Trial Phases

1 Phases

Phase 1:1

Drug Approvals

2

FDA:2

Drug Approvals

Ascor

Approval Date
Jan 25, 2024
FDA

Ascor L 500

Approval Date
Apr 4, 2017
FDA

Clinical Trials

Distribution across different clinical trial phases (1 trials with phase data)• Click on a phase to view related trials

Phase 1
1 (100.0%)

A Pharmacokinetics Study of Intravenous Ascorbic Acid

Phase 1
Completed
Conditions
Pharmacokinetics
Interventions
First Posted Date
2015-08-28
Last Posted Date
2016-03-23
Lead Sponsor
McGuff Pharmaceuticals, Inc.
Target Recruit Count
8
Registration Number
NCT02534753
Locations
🇺🇸

Virginia Commonwealth University, Richmond, Virginia, United States

News

McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility

• McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA. • The approval allows MPI to expand its capabilities as a CMO/CDMO, offering end-to-end drug development and manufacturing services to pharmaceutical companies. • MPI plans to increase production of its Ascorbic Acid Injection (ASCOR) to meet growing national and international demand following the facility's approval. • The new facility will handle NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products, including sterile and hazardous drugs.

McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility

• McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA. • The FDA approval allows MPI to expand its capabilities as a CMO/CDMO, offering integrated drug development and manufacturing services to pharmaceutical companies. • The new facility will support the production of NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products, including sterile and hazardous drugs. • MPI plans to increase production of its FDA-approved Ascorbic Acid Injection (ASCOR) to meet growing customer demands both nationally and internationally.

McGuff Pharmaceuticals Receives FDA Approval for Santa Ana Manufacturing Facility

• McGuff Pharmaceuticals, Inc. (MPI) has secured FDA approval for its state-of-the-art, 86,000-sq.-ft. sterile fill-and-finish pharmaceutical manufacturing plant in Santa Ana, CA. • The FDA approval allows MPI to expand its capabilities as a CMO/CDMO, offering integrated drug development and manufacturing services to pharmaceutical companies. • The new facility will support the production of NDA and ANDA labeled injectable products, contract manufactured products, and clinical trial products, including sterile and hazardous drugs. • MPI plans to increase production of its FDA-approved Ascorbic Acid Injection (ASCOR) to meet growing customer demands following the facility's approval.

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