Tag: Aurobindo Pharma

Aurobindo Pharma arm’s biosimilar gets Health Canada NOC

January 9, 2026 admin

Image used for representational purposes. Photo credits: Special Arrangement Aurobindo Pharma subsidiary CuraTeQ Biologics has received notice of compliance (NOC) from Health Canada’s Biologics and Radiopharmaceutical Drugs Directorate for Dyrupeg, its pegylated filgrastim biosimilar version. A notice of compliance from Health Canada is issued to a drug manufacturer after a successful review, confirming the product…

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U.S. FDA issues five observations to Aurobindo Pharma arm

December 19, 2025 admin

The U.S. FDA inspected Unit-IV of APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations. | Photo Credit: Reuters The U.S.Food and Drug Administration has issued five observations to Aurobindo Pharma subsidiary APL Healthcare’s unit in Andhra Pradesh. The U.S.FDA inspected Unit-IV of…

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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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