Drug Approval | June 13, 2024
Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility
There was no observation related to data integrity reported
There was no observation related to data integrity reported
Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility
Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus
Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025
Greg was also central to the planning, design, and construction of this facility
Largest investment in active pharmaceutical ingredient manufacturing of synthetic medicines in U.S. history
Theophylline is used to treat asthma and chronic obstructive pulmonary disease
Acquisition will advance Merck’s integrated offering for viral vector manufacturing
Establishing Asymchem’s first manufacturing footprint in Europe
Outlook 2024 remains flat CER sales growth and CORE EBITDA margin of high 20s
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