Apotex Receives First U.S. FDA Tentative Approval for a Generic Version of Ozempic® (Semaglutide Injection) in Partnership with Orbicular

WESTON, Fla., April 10, 2026 /PRNewswire/ - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, marking a significant milestone in expanding affordable access to complex peptide therapies for patients across the United States.

This approval reinforces Apotex's leadership in bringing high value, technically challenging medicines that help improve patient access and support a more sustainable healthcare system. It's further proof of the company's longstanding commitment to scientific excellence and advancing complex generics that can help reduce costs for patients and payers.

Developed through a strategic partnership with Orbicular Pharmaceutical Technologies, the Semaglutide Injection program is a result of sophisticated development capabilities, including advanced analytical characterization and deep process understanding.

"This is a clear demonstration of what true partnership can achieve," said Barry Fishman, Chief Corporate Development Officer, Apotex. "As a Force for Health, this milestone reflects Apotex's leadership in bringing together complementary strengths, a shared purpose, and an unwavering commitment to execution excellence."

"Achieving technical equivalence for complex peptide products requires deep scientific rigor, advanced analytical precision, and a highly disciplined development approach," said Dr. M. S. Mohan, Managing Director, Orbicular Pharmaceutical Technologies. "We are proud to have supported Apotex in this important program. Their regulatory leadership coupled with Orbicular's development and execution excellence were central to securing FDA Tentative Approval."

The FDA Tentative Approval underscores the strength of Apotex's global development model and its ability to deliver complex generics that meet rigorous regulatory requirements. Upon becoming eligible for final approval, Apotex's Semaglutide Injection is expected to help broaden patient access to an important therapy area where affordability and availability remain critical.

About Apotex
Apotex Corp., headquartered in Weston, Florida, is an affiliate of Apotex Inc. We improve everyday access to innovative medicines and health products for millions of people around the world, offering a broad portfolio of generic and innovative pharmaceutical and consumer health products. Headquartered in Toronto, with regional offices globally—including in the United States, Mexico, and India—we are the largest Canadian based‑ pharmaceutical company and a health partner of choice across the Americas for pharmaceutical licensing and product acquisitions.

About Orbicular 
Orbicular is a partnership driven, B2B specialty pharmaceutical company focused on designing, developing, and delivering complex generics and specialty pharmaceutical products. With integrated capabilities spanning development, advanced analytical characterization, regulatory strategy, and technology transfer, Orbicular enables partners to bring high-value, technically complex products to global markets.

SOURCE Apotex Corp.