Tag: US FDA

Aurobindo Pharma arm’s New Jersey warehouse gets OAI status after U.S. FDA inspection

February 20, 2025 admin

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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U.S. FDA issues warning letter to Natco over facility near Hyderabad

April 9, 2024 admin

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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Glenmark Pharma’s generic drug to treat psoriatic arthritis gets U.S. FDA approval

October 17, 2023 admin

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…

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