Aurobindo Pharma – Artifex.News

Aurobindo Pharma arm’s biosimilar gets Health Canada NOC

admin — Fri, 09 Jan 2026 17:31:00 +0000

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 meets regulatory standards for safety, efficacy and quality under the Food and Drug Regulations.

For Dyrupeg, the NOC specifically indicates Health Canada has verified high similarity to an approved reference biologic drug, with no clinically meaningful differences in terms of safety, PK/PD or quality attributes, Aurobindo Pharma said on Friday.

In 2025, Dyrupeg had received marketing authorisation in the European Union from the European Commission and from MHRA, UK. There are three other biosimilar applications from CuraTeQ Biologics seeking marketing authorisation that are currently under review with Health Canada, it said.

Published – January 09, 2026 11:01 pm IST

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

admin — Fri, 19 Dec 2025 04:13:00 +0000

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 APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations. Aurobindo Pharma said the observations are procedural in nature and “we will respond to the U.S.FDA within the stipulated timelines.”

The company is committed to maintaining the highest quality manufacturing standards at all its facilities worldwide, it said following the development, which comes close on the heels of the three observations U.S. FDA issued to the active pharmaceutical ingredients (API) manufacturing facility of another subsidiary, Apitoria Pharma, in Hyderabad.

Published – December 19, 2025 09:43 am IST

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

admin — Thu, 20 Feb 2025 05:21:33 +0000

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 recommended by the regulator, for the facility it has inspected.

“The U.S. FDA had conducted an inspection at one of the warehouses of Aurobindo Pharma USA Inc., a 100% subsidiary, situated in East Windsor, New Jersey, from May 13-15, 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA). The inspection had concluded with 5 observations,” the generic drugmaker said.

ALSO READ: Aurobindo Pharma Q3 net declines 10% to ₹846 cr. on lower U.S. formulations revenue

Subsequently, the U.S. FDA has determined the inspection classification status of the warehousing facility as Official Action Indicated (OAI), it said in a filing on Thursday (February 20, 2025).

At this point, it does not foresee any impact on the business and remains committed to work closely with the U.S. FDA to enhance its compliance on an ongoing basis, Aurobindo Pharma said.

Post inspection, U.S. FDA classifies facilities either as No Action Indicated which means no objectionable conditions or practices were found; Voluntary Action Indicated (VAI) that indicates objectionable conditions or practices were found but not meriting administrative or regulatory action from the agency; or OAI.

Aurobindo Pharma shares were 1.17% lower at ₹1,123 apiece on the BSE around 10.30 a.m.

Published – February 20, 2025 10:51 am IST

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