Sunshine Biopharma Gains FDA-Equivalent Clearance in Canada for Domperidone to Treat Cancer-related Nausea

Rhea-AI Summary

Sunshine Biopharma (NASDAQ:SBFM) announced Health Canada approval for Domperidone through its subsidiary Nora Pharma to treat nausea, vomiting and to enhance gastrointestinal motility, including use for chemotherapy-induced nausea.

The approval enables commercialization in Canada and expands Sunshine's generics portfolio. Market data in the release cites global Domperidone sales of $1.36B (2025), North America ~39% share, and Canada ~17% of North America.

Positive

• Health Canada approval received for Domperidone (commercialization in Canada)
• Global market cited at $1.36B for Domperidone in 2025
• North America represents ~39% of global Domperidone sales
• Canada market share ~17% of North America (2025)

Negative

• None.

Insights

Regulatory & Commercial Strategy Analyst

Health Canada approval for Domperidone gives Sunshine Biopharma a clear commercial entry into the Canadian antiemetic market.

Sunshine Biopharma received Health Canada clearance on October 28, 2025 to commercialize Domperidone through its subsidiary Nora Pharma. The drug treats nausea, vomiting and improves gastric motility and is commonly used for chemotherapy-induced nausea when other antiemetics are not tolerated.

The approval directly enables sales in Canada, where the North American Domperidone market represented 17.0% of the regional market in 2025. Global Domperidone sales are cited at $1.36 billion by the end of 2025, and the North American market grew from $440 million in 2021 to $533 million in 2025, with a projected reach of $781 million by 2033 at a CAGR of 4.89%.

Key dependencies and risks are clear and factual: successful commercial launch execution in Canada, uptake by prescribers who use Domperidone for chemotherapy-induced nausea, and Nora Pharma’s ability to capture a share of the Canadian slice of the North American market. Monitorable items include Canadian launch timing, initial sales figures, and market share within Canada versus the cited regional percentages over the next 12–24 months.

FORT LAUDERDALE, FL / ACCESS Newswire / October 28, 2025 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company focused on innovative and affordable healthcare solutions, today announced that its wholly owned subsidiary, Nora Pharma Inc., has received approval from Health Canada, the Canadian equivalent to the FDA, for the commercialization of Domperidone, a prescription medication used to relieve nausea and vomiting and to enhance gastrointestinal motility.

Domperidone is often used for chemotherapy-induced nausea and vomiting, especially when patients cannot tolerate other antiemetics which may cause extrapyramidal side effects. Domperidone works by blocking dopamine receptors in the gut, helping reduce nausea and improve gastric motility.

The approval of Domperidone marks another milestone in Sunshine Biopharma's strategic expansion into the generic pharmaceuticals market. According to Cognitive Market Research, global sales of Domperidone will reach $1.36 billion USD by the end of 2025. North America holds approximately 39% of the global market share. The North American Domperidone industry grew from $440 million USD in 2021 to $533 million USD in 2025. It is estimated that the North American Domperidone industry will reach $781 million USD by 2033, a CAGR of 4.89%. The approximate percentage market share for each of the three North American countries in 2025: United States (73.7%), Canada (17.0%), Mexico (9.30%).

"We are proud of Nora Pharma's continued progress in bringing essential medications to market," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "The approval of Domperidone not only enhances our growing generics portfolio but also reinforces our commitment to improving patient access to effective treatments. Domperidone is widely prescribed for the management of gastrointestinal disorders and is recognized for its efficacy and safety profile. With this approval, Nora Pharma is well-positioned to meet the needs of healthcare providers and patients across Canada."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 76 generic prescription drugs on the market in Canada and more than 12 additional drugs scheduled to be launched in 2026. In addition, Sunshine Biopharma is conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA, an mRNA-Lipid Nanoparticle targeted for liver cancer, and (ii) PLpro protease inhibitor, a small molecule for treatment of SARS Coronavirus infections. For more information, please visit: www.sunshinebiopharma.com.

Safe Harbor Forward-Looking Statements

This press release contains forward-looking statements which are based on current expectations, forecasts, and assumptions of Sunshine Biopharma Inc. (the "Company") that involve risks as well as uncertainties that could cause actual outcomes and results to differ materially from those anticipated or expected. These statements appear in this release and include all statements that are not statements of historical fact regarding the intent, belief or current expectations of the Company, including statements related to the Company's drug development activities, financial performance, and future growth. These risks and uncertainties are further described in filings and reports by the Company with the U.S. Securities and Exchange Commission (SEC). Actual results and the timing of certain events could differ materially from those projected in or contemplated by the forward-looking statements due to a number of factors detailed from time to time in the Company's filings with the SEC. Reference is hereby made to cautionary statements and risk factors set forth in the Company's most recent SEC filings.

For more information, please contact:

Camille Sebaaly, CFO
Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com

SOURCE: Sunshine Biopharma Inc.

View the original press release on ACCESS Newswire

FAQ

What did Sunshine Biopharma (SBFM) announce on October 28, 2025 about Domperidone?

Sunshine Biopharma said its subsidiary Nora Pharma received Health Canada approval to commercialize Domperidone in Canada.

How is Domperidone used clinically and why is the Health Canada approval important for SBFM?

Domperidone is prescribed for nausea, vomiting and to improve gastric motility, including chemotherapy-related nausea; the approval permits commercial sales in Canada.

What market size figures did Sunshine Biopharma cite for Domperidone in the announcement?

The release cites $1.36 billion global Domperidone sales in 2025 and North America holding ~39% of that market.

What percentage of the North American Domperidone market did the company report for Canada in 2025?

The company reported Canada represents about 17% of the North American Domperidone market in 2025.

Does the Health Canada approval immediately affect Sunshine Biopharma (SBFM) revenue guidance?

The announcement confirms regulatory clearance for Canada but does not provide specific revenue or guidance projections.

Will Domperidone be available to Canadian healthcare providers following the approval?

With Health Canada approval, Nora Pharma is positioned to commercialize Domperidone to healthcare providers across Canada.