Zydus Lifesciences Limited has achieved a significant milestone by receiving final approval from the United States Food and Drug Administration (USFDA) to manufacture Ibuprofen and Famotidine tablets 800 mg/26.6 mg. This approval allows Zydus to bring a new treatment alternative to patients suffering from rheumatoid arthritis and osteoarthritis while also helping reduce the risk of upper gastrointestinal ulcers in those requiring long-term ibuprofen use.

The approved formulation is a generic version of Duexis tablets (800 mg/26.6 mg), offering a cost-effective alternative in the US pharmaceutical market. Ibuprofen is a well-known nonsteroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation, while Famotidine is an H2-receptor antagonist that helps protect the stomach lining from ulcers by reducing acid production.

Zydus Expands its US Market Reach

With this latest approval, Zydus Lifesciences continues to strengthen its foothold in the US generic drug market. The company has now received 415 final USFDA approvals and has filed 483 Abbreviated New Drug Applications (ANDAs) since FY 2003-04. This accomplishment underscores Zydus’ commitment to delivering high-quality, affordable medications across global markets.

The newly approved Ibuprofen and Famotidine tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad, ensuring compliance with stringent USFDA manufacturing standards.

Market Impact and Sales Projections

The Ibuprofen and Famotidine tablet market in the US was valued at approximately USD 3.6 million, as per IQVIA MAT December 2024 data. With Zydus entering this segment, the company aims to capture a significant market share by offering a cost-effective alternative to branded Duexis tablets.

Benefits of Ibuprofen and Famotidine Combination

The combination of Ibuprofen and Famotidine provides a dual benefit:

• Pain Relief and Inflammation Reduction – Ibuprofen effectively manages arthritis symptoms, muscle pain, and joint stiffness.
• Ulcer Prevention – Famotidine helps lower the risk of gastric and duodenal ulcers in patients who require long-term NSAID therapy.

For individuals suffering from rheumatoid arthritis and osteoarthritis, long-term NSAID usage can increase the risk of stomach ulcers and gastrointestinal bleeding. By incorporating Famotidine, this medication reduces those risks, making it a safer choice for chronic pain management.

Zydus Lifesciences: Driving Innovation in Pharma

As a leading player in the global pharmaceutical industry, Zydus Lifesciences continues to focus on research, innovation, and affordability. The company's expanding portfolio of USFDA-approved drugs demonstrates its dedication to providing high-quality medicines for critical therapeutic areas.

With this latest approval, Zydus is well-positioned to strengthen its generic drug offerings while ensuring patients receive effective and affordable treatment options for arthritis and gastrointestinal ulcer prevention.

Zydus Lifesciences remains committed to expanding its pharmaceutical portfolio, meeting global healthcare needs, and providing innovative solutions for patients worldwide.

The Upcoming IPOs in this week and coming weeks are Nukleus Office, Shreenath Paper.

The Current active IPO are Beezaasan Explotech, Swasth Foodtech, HP Telecom India.

Start your Stock Market Journey and Apply in IPO by Opening Free Demat Account in Choice Broking FinX.

Join our Trading with CA Abhay Telegram Channel for regular Stock Market Trading and Investment Calls by CA Abhay Varn - SEBI Registered Research Analyst.

Join our Finance Saathi Telegram Channel for Regular Share Market, News & IPO Update.