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

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.

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