Aurobindo Pharma Limited has achieved a significant regulatory milestone through its subsidiary Curateq Biologics, which has received approval from Health Canada for its Dyrupeg biosimilar product. This approval marks an important step in the company's biologics portfolio expansion and entry into the Canadian market.

Regulatory Approval Details

Health Canada has granted approval for Dyrupeg, confirming that the biosimilar product meets the comprehensive safety, efficacy, and quality standards mandated by Canadian regulatory authorities. The approval process involves rigorous evaluation of clinical data and manufacturing standards to ensure the biosimilar demonstrates comparable therapeutic effects to the reference product.

Strategic Significance

The Health Canada approval for Dyrupeg represents a crucial development for Curateq Biologics and strengthens Aurobindo Pharma's position in the biosimilars market. This regulatory success demonstrates the company's capability to develop complex biological products that meet international regulatory standards and opens opportunities for market penetration in Canada.

The approval validates Curateq Biologics' research and development capabilities and manufacturing processes, positioning the subsidiary as a credible player in the competitive biosimilars landscape. This achievement may serve as a foundation for future regulatory submissions and product launches in the Canadian market.

Aurobindo Pharma Limited has announced an upcoming investor group plant visit arranged by Investec, scheduled for January 13, 2026. The pharmaceutical company informed both the National Stock Exchange of India Limited and BSE Limited about this investor engagement through a regulatory filing dated January 8, 2026.

Visit Details and Schedule

The investor group plant visit will be conducted as an in-person meeting at the company's manufacturing facilities in Vizag and Kakinada. The comprehensive facility tour is scheduled to run from 09:00 AM to 05:00 PM IST, providing investors with an extended opportunity to examine the company's operations.

Regulatory Compliance and Information Sharing

Aurobindo Pharma has explicitly stated that no unpublished price sensitive information (UPSI) is intended to be discussed during the interactions with investors. This disclosure ensures compliance with regulatory requirements and maintains transparency in investor communications.

The company has also noted that the schedule of the plant visit remains subject to potential changes. Any modifications may occur due to exigencies on the part of either the investor group or the company itself.

Corporate Communication

The announcement was made through official communication to both major Indian stock exchanges, where Aurobindo Pharma Limited trades under the symbol AUROPHARMA on NSE and company code 524804 on BSE. The filing was digitally signed by B. Adi Reddy, Company Secretary, ensuring proper authorization and documentation of the investor engagement activity.

This plant visit represents part of Aurobindo Pharma's ongoing investor relations activities, providing institutional investors with direct access to the company's manufacturing operations and facilities across its key production locations in Andhra Pradesh.