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Zydus Lifesciences has received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL). The product, primarily used for the short-term treatment of scurvy, is a generic of reference listed drug Ascor Injection. The…
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The U.S. Food and Drug Administration (U.S. FDA) has issued one observation to AuroPeptides, the peptide API manufacturing subsidiary of Aurobindo Pharma, following a routine inspection of its facility in Sangareddy district near Hyderabad from August 17 to 21. The observation relates to facility and equipment maintenance and does not pertain to data integrity or…
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Representational image of Aurobindo Pharma’s Unit IX in Andhra Pradesh | Photo Credit: A. Roy Chowdhury The U.S. Food and Drug Administration (U.S. FDA) has classified a warehouse of Aurobindo Pharma subsidiary in New Jersey, U.S. as Official Action Indicated (OAI) after an inspection it conducted. Such a classification means regulatory and/or administrative actions are…
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Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest. | Photo Credit: Reuters The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality…
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Drug-maker Glenmark Pharmaceuticals’ Apremilast Tablets, 10 mg, 20 mg and 30 mg, a generic version of Amgen’s Otezla Tablets, 10 mg, 20 mg and 30 mg, has received final approval from the United States Food and Drug Administration (U.S. FDA). Otezla Tablets brand and therapeutic equivalents achieved annual sales of around $3.7 billion, Glenmark said…
Read More “Glenmark Pharma’s generic drug to treat psoriatic arthritis gets U.S. FDA approval ” »