Dr. Reddy's Laboratories has announced the launch of an oral Semaglutide biosimilar for the treatment of Type 2 diabetes in India, further strengthening its growing GLP-1 therapy portfolio. This development follows the company's earlier launch of a generic Semaglutide Injection in Canada on May 15, 2026, after receiving a Notice of Compliance (NOC) from Health Canada on April 28, 2026. Together, these launches mark a significant expansion of Dr. Reddy's Semaglutide presence across both oral and injectable formulations in multiple geographies.

India: Oral Semaglutide Biosimilar Launch

Dr. Reddy's has introduced an oral Semaglutide biosimilar in India targeting patients with Type 2 diabetes mellitus. This adds to the company's existing injectable Semaglutide offering in India, which was launched under the brand name Obeda®. The introduction of an oral formulation represents a meaningful expansion of the company's domestic GLP-1 product portfolio, offering patients an additional treatment option.

Canada Launch: Key Details

The generic Semaglutide Injection launched in Canada is indicated for the once-weekly treatment of adults with Type 2 diabetes mellitus, to improve glycemic control in combination with diet and exercise. It is supplied as a sterile solution for subcutaneous injection in a pre-filled pen. Canada holds the distinction of being the first G7 country to grant market authorization for a generic Semaglutide Injection. The following table outlines the key product and launch parameters for the Canadian market:

CEO Statement

Erez Israeli, Chief Executive Officer of Dr. Reddy's, commented on the milestone: "We are pleased to launch our generic Semaglutide Injection in Canada, within days of receiving Health Canada approval. The milestone highlights our readiness to serve the Canadian patients, supported by our deep expertise in complex drug and peptide development. With a well-established presence and strong market access capabilities in Canada, we remain committed to bringing advanced, high-quality, and affordable GLP-1 therapies closer to patients. The Canada launch builds on the momentum of our recent launch in India under the brand name Obeda®. As GLP-1 therapies continue to be a key focus area for us, we are actively working to expand access across multiple global markets."

Global Expansion Strategy

The launches in India and Canada reflect Dr. Reddy's broader Semaglutide strategy, which encompasses both oral and injectable formulations across multiple global markets. The company has outlined plans to introduce both formats across all markets in the future, reinforcing its ambition to diversify its GLP-1 product portfolio. Dr. Reddy's is a global pharmaceutical company headquartered in Hyderabad, India, established in 1984, with major markets including the USA, India, Russia & CIS countries, China, Brazil, and Europe.

Dr Reddy's Laboratories reported a sharp decline in its financial performance for the quarter ended March 31, 2026, primarily impacted by specific one-time items including a shelf stock adjustment and impairment charges. The company's consolidated net profit for Q4FY26 stood at ₹220 Cr, a significant decrease of 86% compared to the corresponding period in the previous year. Revenue from operations for the quarter was ₹7,516 Cr, marking a 12% year-on-year decline. The board recommended a final dividend of ₹8 per share during the quarter.

Q4 Financial Performance

The company reported an EBITDA of ₹981 Cr for the quarter, down 60% year-on-year, with an EBITDA margin of 13%. The financial results were adversely affected by specific items, including a shelf stock adjustment (SSA) of ₹453 Cr related to lenalidomide, a VAT liability provision of ₹114 Cr, and an impairment of CAR-T & Eftilagimod Alfa amounting to ₹228 Cr. Excluding these specific items, the EBITDA margin was reported at 19.5%.

FY26 Financial Highlights

For the full fiscal year FY26, the company reported revenues of ₹33,593 Cr, a 3% year-on-year increase. Profit after tax (PAT) for the year stood at ₹4,285 Cr, down 24% YoY, while EBITDA was ₹7,659 Cr, a decline of 17% YoY with a margin of 23%. Excluding the impact of specific items such as the SSA, VAT liability, and impairment charges, the company noted a double-digit growth in its base business. Excluding the one-time SSA of ₹453 Cr, revenues for FY26 were ₹34,046 Cr, representing a growth of 4.6%. The Return on Capital Employed (RoCE) for the year was reported at 16%, which improved to 17.5% when excluding the impact of specific items.

Segment Performance

Revenue from North America fell 51% year-on-year to ₹1,756 Cr, largely due to lower lenalidomide sales and the one-time shelf stock adjustment. Excluding the SSA, North America revenues declined by 38%. Conversely, Emerging Markets revenues grew 29% to ₹1,806 Cr, driven by new product launches and favorable forex. India revenues increased 20% to ₹1,566 Cr, supported by new brand launches and acquisitions, while Europe revenues rose 14% to ₹1,452 Cr, aided by forex tailwinds.

Operational and Business Highlights

Despite the quarterly decline, the company highlighted double-digit growth in its base business, excluding the impact of lenalidomide and its SSA. Dr Reddy's secured approval for generic semaglutide injection in Canada and launched the product under the brand name 'Obeda' in India. The company also forayed into Hormone Replacement Therapy with the acquisition of Progynova and Cyclo-Progynova in India. Additionally, the Biologics Licence Application (BLA) for its abatacept biosimilar was accepted for review by the USFDA. The company also completed the integration of 95% of the acquired NRT business by value as of March 2026.

Regulatory Disclosures

In compliance with SEBI's listing regulations, Dr Reddy's filed a disclosure on May 12, 2026, sharing the audio recording of its Q4FY26 earnings call conducted on the same date, pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The filing was submitted to the National Stock Exchange of India, BSE Limited, New York Stock Exchange, and NSE IFSC Ltd., and the recording has been made available on the company's official website. Subsequently, on May 13, 2026, the company submitted copies of the newspaper advertisement regarding the audited financial results to the stock exchanges, confirming publication in Business Standard and Andhra Prabha, pursuant to Regulation 47 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Further, on May 18, 2026, the company filed the transcript of the earnings call for the quarter and financial year ended March 31, 2026, with the stock exchanges pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The transcript has been made available on the company's official website.