Dr. Reddy's Launches Generic Semaglutide Injection in Canada, First G7 Market Authorization

2 min read     Updated on 16 May 2026, 07:06 AM
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Dr. Reddy's Laboratories launched its generic Semaglutide Injection in Canada on May 15, 2026, following Health Canada's Notice of Compliance on April 28, 2026, making Canada the first G7 country to grant such authorization. The product, available in 2 mg/pen and 4 mg/pen strengths, targets once-weekly treatment of type 2 diabetes in adults. The company plans to expand both oral and injectable Semaglutide formulations across all global markets, building on its earlier India launch under the brand name Obeda®.

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Dr. Reddy's Laboratories has announced the launch of its generic Semaglutide Injection in Canada on May 15, 2026, following the receipt of a Notice of Compliance (NOC) from Health Canada on April 28, 2026. The company is among the first to introduce a generic Semaglutide Injection in the Canadian market, and Canada holds the distinction of being the first G7 country to grant market authorization for generic Semaglutide Injection. This launch builds on the company's earlier rollout in India under the brand name Obeda®, reinforcing Dr. Reddy's expanding presence in the global GLP-1 therapy segment.

Canada Launch: Key Details

The generic Semaglutide Injection 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. The following table outlines the key product and launch parameters:

Parameter: Details
Product: Generic Semaglutide Injection
Launch Market: Canada
Regulatory Approval: Notice of Compliance (NOC) from Health Canada, April 28, 2026
Launch Date: May 15, 2026
Indication: Once-weekly treatment of adults with type 2 diabetes mellitus
Formulation: Sterile solution for subcutaneous injection in pre-filled pen
Available Strengths: 2 mg/pen and 4 mg/pen (concentration: 1.34 mg/ml)
Dose Delivery: 2 mg/pen: 0.25 mg or 0.5 mg doses; 4 mg/pen: 1 mg doses
India Brand Name: Obeda®
Future Formats: Oral and Injectable
Future Markets: All markets

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 Canada launch marks a significant step in Dr. Reddy's broader Semaglutide strategy. The company has outlined plans to introduce both oral and injectable formulations of Semaglutide across all markets in the future, reflecting its ambition to diversify its GLP-1 product portfolio and strengthen its pharmaceutical footprint across multiple geographies. 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.

Historical Stock Returns for Dr Reddys Laboratories

1 Day5 Days1 Month6 Months1 Year5 Years
+2.54%+2.23%+8.16%+7.28%+9.57%+28.61%

Which other G7 or major markets are likely to grant regulatory approval for generic Semaglutide next, and how quickly could Dr. Reddy's capitalize on those opportunities?

How might Novo Nordisk respond competitively to the entry of generic Semaglutide in Canada, particularly through pricing strategies or patent litigation?

What is the projected timeline for Dr. Reddy's to launch its oral Semaglutide formulation globally, and how significant could that segment be relative to the injectable market?

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Dr Reddy's Net Profit Falls 86% to ₹220 Cr in Q4

3 min read     Updated on 14 May 2026, 09:45 AM
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Dr Reddy's Laboratories reported an 86% YoY decline in Q4FY26 net profit to ₹220 Cr, impacted by one-time charges including a shelf stock adjustment and impairment. Revenue decreased 12% to ₹7,516 Cr, and the board recommended a final dividend of ₹8 per share. The company also filed regulatory disclosures regarding the publication of its audited financial results.

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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%.

Metric Q4FY26 Q4FY25 YoY Change
Net Profit (₹ Cr) 220 1,594 ↓ 86%
Revenue (₹ Cr) 7,516 8,506 ↓ 12%
EBITDA (₹ Cr) 981 2,475 ↓ 60%
EBITDA Margin 13.00% 29.10% N/A

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.

Historical Stock Returns for Dr Reddys Laboratories

1 Day5 Days1 Month6 Months1 Year5 Years
+2.54%+2.23%+8.16%+7.28%+9.57%+28.61%

How will Dr. Reddy's North America revenue trajectory evolve in FY27 as lenalidomide sales continue to normalize and new product launches like generic semaglutide gain traction?

What is the potential timeline and market opportunity for Dr. Reddy's abatacept biosimilar following USFDA's acceptance of the BLA for review?

Could the impairment of CAR-T and Eftilagimod Alfa signal a broader strategic retreat from advanced oncology and immuno-oncology pipelines, and how might this reshape R&D spending priorities?

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