Clinical Trials
1
0 active
Approvals
4
Total approvals
Agencies
1
Regulatory bodies
Founded
N/A
Completed
1
100.0%
- Zydus Lifesciences received final USFDA approval for its Ascorbic Acid Injection USP in strengths of 25,000 mg/50 mL and 5,000 mg/10 mL (500 mg/mL). - The injection is indicated for short-term treatment of scurvy in adult and pediatric patients aged 5 months and older when oral administration is not feasible. - The USFDA granted 180 days of Competitive Generic Therapy (CGT) exclusivity, commencing from the first day of commercial marketing. - The product, a generic equivalent of McGuff Pharmaceuticals' Ascor (annual US sales of about $11.6 million), will be manufactured at Zydus' Jarod facility in Gujarat.
• 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, 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, 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.
