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Health Canada Approves Sunshine Biopharma's Ondansetron for Treatment of Chemotherapy-Induced Nausea and Vomiting

(Neutral)
(Very Positive)
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Sunshine Biopharma (NASDAQ:SBFM) announced that Health Canada has approved its generic Ondansetron 4mg and 8mg tablets, including standard film-coated and Oral Disintegrating Tablet (ODT) forms, for the Canadian market. Ondansetron is the generic equivalent of Zofran® and is prescribed for nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery.

According to Sunshine Biopharma, the launch expands its portfolio into chemotherapy‑related nausea and vomiting, leveraging its Canadian distribution network via subsidiary Nora Pharma. The company expects Ondansetron to be ready for shipment to pharmacies by the end of 2026 and currently markets 60 generic drugs in Canada, with about 12 more scheduled for launch in 2026.

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Positive

  • Health Canada approval for 4mg and 8mg Ondansetron tablets, including ODT
  • Strategic expansion into nausea and vomiting from cancer therapy segment
  • Established Canadian distribution via wholly owned subsidiary Nora Pharma
  • Portfolio scale: 60 generic drugs currently on Canadian market
  • Planned launches: approximately 12 additional generic drugs in 2026
  • Targets growing global nausea medicine market projected at $4.86 billion by 2032

Negative

  • None.

News Market Reaction – SBFM

-6.54%
12 alerts
-6.54% Session close to close
-24.5% Trough in 31 hr 54 min
$3.76M Market Cap
1.4x Rel. Volume

In the Jul 28 session, SBFM declined 6.54%, reflecting a notable negative market reaction. Argus tracked a trough of -24.5% from its starting point during tracking. Our momentum scanner triggered 12 alerts that day, indicating notable trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.5% in the session following this news. Historical event 1064851 recorded a -5.94%...
Analysis

The stock moved -6.5% in the session following this news. Historical event 1064851 recorded a -5.94% 24-hour reaction to another Canadian generic approval. That comparison frames approval news as inconsistent in SBFM's record; low short positioning was also recorded without establishing a price outcome.

Key Figures

Tablet strengths: 4mg and 8mg Nausea medicine market: $3.17 billion Nausea medicine market: $4.86 billion +4 more
7 metrics
Tablet strengths 4mg and 8mg Generic Ondansetron tablets approved for the Canadian market
Nausea medicine market $3.17 billion Global market estimate for 2025
Nausea medicine market $4.86 billion Global market expectation for 2032
Market CAGR 6.3% Global nausea medicine market, 2025 to 2032
Canadian pharmaceutical market share 2.1% Share of the global pharmaceutical market
Expected pharmacy shipment end of 2026 Ondansetron availability in Canadian pharmacies
Generic drugs on market 60 drugs Sunshine Biopharma portfolio in Canada

Historical Context

5 past events · Latest: Jul 20 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 20 Research publication Positive -3.9% Peer-reviewed PLpro inhibitor research showed activity across variants and efficacy in a mouse model.
Jun 25 Canadian drug approval Positive +4.9% Canadian approval covered generic anastrozole tablets distributed through Nora Pharma before year-end shipping.
Jun 01 Canadian drug approval Positive -5.9% Canadian approval covered generic rivaroxaban tablets with planned October 2026 shipping.
May 29 Patent issuance Positive -19.8% U.S. patent covered PLpro inhibitors advancing toward GLP studies before clinical trials.
May 28 Reverse stock split Neutral -25.3% Reverse split targeted Nasdaq minimum bid-price compliance and reduced outstanding shares.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent history showed negative 24-hour reactions for four of five events, while the June 25 Canadian approval was followed by a positive 4.9% reaction.

Key Terms

5-ht3 receptor antagonist, oral disintegrating tablets, cagr
3 terms
5-ht3 receptor antagonist medical
"Ondansetron is a prescription serotonin 5-HT3 receptor antagonist."
A 5-HT3 receptor antagonist is a type of drug that blocks specific nerve receptors in the body that receive serotonin signals, preventing those signals from triggering nausea and vomiting. For investors, these drugs matter because they can become commercially important treatments for chemotherapy- or surgery-induced nausea and other conditions; successful clinical trial results, regulatory approvals, patent protection, or new delivery methods can drive sales, partnerships, and stock value.
oral disintegrating tablets medical
"standard film-coated tablets and Oral Disintegrating Tablets (Ondansetron ODT)"
Oral disintegrating tablets are solid medication tablets engineered to dissolve or break apart quickly in the mouth without needing water, similar to how a breath mint melts on the tongue. They matter to investors because they can expand a drug’s market by improving patient convenience and adherence, affect manufacturing and packaging costs, and face specific regulatory and patent considerations that influence a product’s commercial value.
cagr financial
"exhibiting a compound annual growth rate (CAGR) of 6.3%."
Compound Annual Growth Rate (CAGR) measures the average yearly growth of an investment, revenue, or other metric over a multi-year period as if it had grown at a steady rate each year. Think of it like the constant speed that would take you from the starting value to the ending value over the same time—useful because it smooths out ups and downs and lets investors compare different assets or performance periods on an even footing.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FORT LAUDERDALE, FL / ACCESS Newswire / July 28, 2026 / Sunshine Biopharma Inc. (NASDAQ:SBFM) (the "Company"), a leading pharmaceutical company specializing in generic and specialty prescription medications, is pleased to announce the approval of its generic Ondansetron tablets of 4mg and 8mg for the Canadian market. Ondansetron is the generic equivalent of the brand name, Zofran®.

Ondansetron is highly prescribed for nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. Ondansetron is a prescription serotonin 5-HT3 receptor antagonist. It works by blocking the actions of chemicals in the body that trigger nausea and vomiting. By offering both standard film-coated tablets and Oral Disintegrating Tablets (Ondansetron ODT), healthcare providers can better tailor the treatment to individual patient needs and physical condition.

According to Coherent Market Insights, the global Nausea Medicine Market is estimated to be valued at $3.17 billion in 2025 and is expected to reach $4.86 billion in 2032, exhibiting a compound annual growth rate (CAGR) of 6.3%. The global Nausea Medicine Market is growing steadily, fueled by increasing cases of nausea related to chemotherapy, motion sickness, gastrointestinal issues, and pregnancy. According to IQVIA Pharmafocus 2028, the Canadian pharmaceutical market accounts for approximately 2.1% of the global pharmaceutical market and ranks as the 6th largest worldwide.

Sunshine Biopharma has established a robust distribution network across Canada through its wholly owned Canadian subsidiary, Nora Pharma Inc. The addition of Ondansetron to our portfolio of drugs represents a strategic expansion for the Company into the area of nausea and vomiting caused by cancer therapy. The Company anticipates that its Ondansetron will be ready to ship to pharmacies by the end of 2026.

"We are pleased to introduce Ondansetron oral tablets and Ondansetron ODT as the newest addition to our expanding portfolio of high-quality generic drugs," said Dr. Steve Slilaty, CEO of Sunshine Biopharma. "This approval strengthens our position in the generics market and reflects our ongoing commitment to delivering affordable medicines that patients and healthcare providers can rely on."

About Sunshine Biopharma Inc.

Sunshine Biopharma currently has 60 generic prescription drugs on the market in Canada and approximately 12 additional drugs scheduled to be launched in the remainder of 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.

All registered trademarks are the property of their respective owners.

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 Health Canada approve for Sunshine Biopharma (NASDAQ:SBFM) on July 28, 2026?

Health Canada approved Sunshine Biopharma’s generic Ondansetron 4mg and 8mg tablets, including ODT, for the Canadian market. According to Sunshine Biopharma, Ondansetron is the generic equivalent of Zofran® and is indicated for nausea and vomiting linked to chemotherapy, radiation, and surgery.

When will Sunshine Biopharma’s Ondansetron (SBFM) be available in Canadian pharmacies?

Sunshine Biopharma anticipates its Ondansetron products will be ready to ship to Canadian pharmacies by the end of 2026. According to Sunshine Biopharma, this timing applies to both standard film-coated tablets and Oral Disintegrating Tablets distributed through its Nora Pharma subsidiary.

How does Ondansetron from Sunshine Biopharma (SBFM) work for chemotherapy-induced nausea and vomiting?

Ondansetron is a serotonin 5-HT3 receptor antagonist that blocks body chemicals triggering nausea and vomiting. According to Sunshine Biopharma, it is prescribed for nausea and vomiting associated with cancer chemotherapy, radiation therapy, and surgery, offering both standard tablets and ODT for tailored patient treatment.

What market opportunity does Ondansetron create for Sunshine Biopharma (NASDAQ:SBFM)?

The product positions Sunshine Biopharma in the growing global nausea medicine market. According to Sunshine Biopharma, Coherent Market Insights estimates this market at $3.17 billion in 2025, reaching $4.86 billion by 2032, driven by chemotherapy, motion sickness, gastrointestinal issues, and pregnancy-related nausea.

How many generic drugs does Sunshine Biopharma (SBFM) currently market in Canada?

Sunshine Biopharma currently has 60 generic prescription drugs on the Canadian market. According to Sunshine Biopharma, approximately 12 additional generic drugs are scheduled to be launched during the remainder of 2026, complementing the newly approved Ondansetron products and expanding its portfolio breadth.

What role does Nora Pharma play in Sunshine Biopharma’s Ondansetron (SBFM) rollout in Canada?

Nora Pharma is Sunshine Biopharma’s wholly owned Canadian subsidiary operating its distribution network. According to Sunshine Biopharma, this established network will support the introduction of Ondansetron tablets and ODT across Canada, enabling pharmacies and healthcare providers to access the new generic nausea treatment.