Tag: Aurobindo Pharma

India initiates anti-dumping probe on Pen-G, salts from China

Posted on By admin
India initiates anti-dumping probe on Pen-G, salts from China

Anti-Dumping Duty words on the page and glasses. | Photo Credit: The Hindu India has initiated an anti-dumping investigation into imports of Penicillin G and its salts from China after domestic manufacturer Lyfius Pharma alleged the imports were causing material retardation to the industry. The company has sought imposition of anti-dumping duties, the Directorate General…

Read More “India initiates anti-dumping probe on Pen-G, salts from China” »

Business

Aurobindo Pharma arm’s biosimilar gets Health Canada NOC

Posted on By admin
Aurobindo Pharma arm’s biosimilar gets Health Canada NOC

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…

Read More “Aurobindo Pharma arm’s biosimilar gets Health Canada NOC” »

Business

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

Posted on By admin
U.S. FDA issues five observations to Aurobindo Pharma arm

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…

Read More “U.S. FDA issues five observations to Aurobindo Pharma arm” »

Business

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

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

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…

Read More “Aurobindo Pharma arm’s New Jersey warehouse gets OAI status after U.S. FDA inspection ” »

Business