Dr Reddy’s Semaglutide Canada: DINs Received, NOC Pending

Regulatory status: approval still not final

Dr. Reddy’s Laboratories has told exchanges that it is still awaiting Health Canada’s final “Notice of Compliance” (NOC) for its Semaglutide Injection. The update followed market reports and investor focus on the company’s timeline for launching a generic semaglutide injectable in Canada. While the NOC has not been issued yet, the company described the project as an active priority under ongoing regulatory review. Dr. Reddy’s also said it continues to work with regulators to meet remaining requirements for the Canadian market.

The clarification matters because Canada is being closely tracked as a high-value opportunity for GLP-1 therapies, especially as exclusivities end and multiple manufacturers prepare filings. For investors, the key variable remains the timing of the final regulatory step, since commercial launch is typically linked to the issuance of the NOC.

Key milestone: Health Canada DINs received on April 22, 2026

Dr. Reddy’s confirmed it received Drug Identification Numbers (DINs) for Semaglutide Injection on April 22, 2026. DINs are a formal identifier in Canada’s regulatory system and indicate a product has progressed through critical parts of the pathway. The company positioned the DIN milestone as an important step while it continues engagement with Health Canada for the final NOC.

The company has not stated that the DINs equal final approval. It has explicitly said the Notice of Compliance is still pending. As a result, the market is now watching for the final regulatory communication that enables commercial sale.

Management commentary: launch window depends on approval

During the Q3 FY26 earnings call, CEO Erez Israeli said the company had submitted its response to the Pharmaceutical Drugs Directorate in Canada and was planning for a launch anytime between February and May, subject to approval. He also indicated the company expects competition in Canada eventually. On the same call, management said no plant inspections were expected or needed, while acknowledging that additional queries are possible in a normal regulatory process.

Israeli told investors that if approval comes through, the company expects to enter either alone or alongside a small number of competitors. The management’s framing ties the Canada launch directly to the regulator’s response timeline, rather than operational readiness.

What delayed Canada: October 2025 Notice of Non-Compliance

Dr. Reddy’s has previously disclosed that Health Canada issued a Notice of Non-Compliance (NON) in October 2025, seeking additional information and clarifications on specific aspects of its Abbreviated New Drug Submission for Semaglutide Injection. Management said it submitted its response by mid-November 2025, within the stipulated timeline, and has been awaiting the regulator’s response since then.

The NON was also reflected in market reaction at the time. Reports said Dr. Reddy’s shares dropped nearly 6% on October 30 and traded around Rs 1,180.90, while the Nifty Pharma index was down about 0.7% in that session. Separate market reports also noted a fall of more than 5% in U.S.-listed shares overnight.

Pricing signals and competitive landscape

Analysts cited in the reports expect Dr. Reddy’s to price its semaglutide brand in Canada between $10 and $10 per unit, with the CEO indicating that in most markets the product would be launched at the lower end of this range. The company’s remarks suggest a pricing strategy aimed at being competitive at launch, particularly if entry is alongside only a few players.

Canada’s environment is evolving quickly. Reports noted that the once-weekly injectable for type-2 diabetes and weight-loss lost patent protection earlier in the month, and a Reuters report referenced an e-pharmacy platform, SaveRxCanada, offering a compounded version by sourcing from India-based manufacturers. Dr. Reddy’s timeline, however, remains tied to the formal Health Canada approval pathway.

India plans: approval secured for diabetes, more pending

For India, Israeli said Dr. Reddy’s has secured regulatory approval and aims to launch the product soon after the patent expires. The company has stated the molecule loses exclusivity on March 20, with a planned launch date referenced as March 21. Management also said its current Indian formulation approval is for type-2 diabetes indications and it is awaiting clearance for weight-loss use.

Israeli told investors that in March it would launch the generic version of Ozempic, with “the other part of the product” to be launched later post approval. Reports also noted that other companies have secured approvals for the type-2 diabetes indication, and additional players have received favourable recommendations from the Subject Expert Committee.

Supply readiness and international filings

On capacity and supply, management has said it holds inventory of about 12 million semaglutide pens and is prepared to scale up to 15 million depending on demand. Beyond India and Canada, Dr. Reddy’s said it secured a Certificate of Pharmaceutical Product (CoPP), enabling export and registrations in other markets. Israeli said filings via the CoPP route are in over 80 markets, while a separate report cited filings in 87 countries.

The company also flagged Brazil as a significant opportunity after India and Canada, with semaglutide expected to go off-patent there in July, as per management commentary.

Why the market is focused: revenue estimates and opportunity size

Brokerage commentary cited in market reports suggested the Canadian approval delay could put forecasted Canadian semaglutide revenues of $10 million (USD million) for FY26 and $100 million (USD million) for FY27 at risk. Another report cited Morgan Stanley estimating $198 million (USD million) in Canadian sales, potentially accounting for about 5% of the company’s total revenue in FY27.

Some market commentary also referenced Canada semaglutide annual sales of $1,600 million (USD million) and company confidence of achieving at least $100 million (USD million) in revenue in the initial phase, though these were presented as estimates rather than reported sales.

GLP-1 demand backdrop: a fast-growing therapy market

The reports described the GLP-1 led anti-obesity market as the fastest-growing therapeutic segment globally, projected to cross $100,000 million (USD million) by the end of the decade. In India, PharmaTrac data cited in the coverage pointed to a tenfold market increase since 2022, including a jump of over 150% following the entry of brands such as Mounjaro (tirzepatide), Wegovy, and Ozempic last year.

This demand backdrop explains why timelines for regulatory approvals, launch sequencing, and competitive entry are being monitored closely, especially in markets where exclusivities are ending.

Key facts at a glance

What to watch next

The immediate next trigger is Health Canada’s decision on the pending Notice of Compliance for Dr. Reddy’s Semaglutide Injection. The company has positioned the file as an active priority and says it remains engaged with regulators after receiving DINs. Any additional regulator queries, if raised, would be part of the normal review process described by management.

In parallel, investors will track execution on India’s planned March launch under the currently approved indication set, and watch whether the company receives further clearances for weight-loss use. With management indicating international registrations through the CoPP route and readiness to deploy existing pen inventory across markets, the key variable remains timing of approvals in Canada and other major off-patent markets.