Aurobindo Pharma’s arm receives Notice of Compliance for ‘Dyrupeg’

09 Jan 2026 Evaluate

Aurobindo Pharma’s wholly owned subsidiary -- CuraTeQ Biologics has obtained Notice of Compliance (NOC) from Biologics and Radiopharmaceutical Drugs Directorate (BRDD) for its pegylated filgrastim biosimilar version -- Dyrupeg. 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 that 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. 

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

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

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1198.50 -8.30 (-0.69%)
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