This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles
Hyper-automated AI is a unified framework combining AI, ML, RPA, and NLQ to streamline data extraction, quality management, transformation, and actionable insights - all on a single platform
Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone
Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
With over 28 years of experience in the pharmaceutical industry, he is a seasoned Techno? Commercial professional and accomplished top management leader
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a hormonal mechanism that occurs in male rats
The conference featured comprehensive discussions, field visits, and knowledge-sharing sessions addressing different aspect of major NCDs
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
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