Aurobindo biologics arm CuraTeQ secures Health Canada nod for Dyrupeg

Aurobindo Pharma on Friday, January 9,  said its biologics arm CuraTeQ Biologics has received a Notice of Compliance (NOC) from Health Canada for Dyrupeg, marking a key regulatory milestone for the company.

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, obtained the approval after a successful review by Health Canada, confirming that the product meets the required regulatory standards. The NOC is issued only after authorities are satisfied with the safety, efficacy and quality of a drug.

Dyrupeg is CuraTeQ’s biosimilar product, and the approval signals Health Canada’s confirmation of its compliance with established regulatory requirements following a detailed assessment. The company said the review process was completed successfully, leading to the issuance of the NOC.

Earlier this month, Aurobindo Pharma, through its subsidiary Auro Pharma Ltd, acquired Khandelwal Laboratories’ non-oncology prescription business for ₹325 cr. The acquisition added 23 established brands

and around 470 employees to Aurobindo’s domestic operations. The deal strengthens the company’s presence in the pain management and anti-infective segments in India.

In December, CuraTeQ Biologics mutually terminated its biosimilar agreement with US-based BioFactura for the product BFI-751. The company cited portfolio prioritisation for ending the partnership and said the decision would not impact its broader biosimilars strategy.

Las month, the US Food and Drug Administration also completed an inspection of the company's wholly owned subsidiary, Apitoria Pharma Unit-V in Telangana, issuing Form 483 with three procedural observations. The company stated that the observations would have no impact on operations.

Shares of Aurobindo Pharma Limited closed lower on the NSE on January 9, with the stock down 0.61% at ₹1,198.80.