WESTON, Fla., April 14, 2026 /PRNewswire/ - Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, today announced that the U.S. Food and Drug Administration (FDA) has approved two Abbreviated New Drug Application (ANDA) for generic Infuvite® Adult Injection (Single Dose and Pharmacy Bulk Package), with eligibility for 180‑day Competitive Generic Therapy (CGT) exclusivity for the pharmacy bulk package. Apotex is the ANDA applicant and will lead commercialization in the United States.
"Securing this approval reflects the strength of our partnership model and our shared commitment to supporting reliable access to high quality injectable products for the U.S. market. Achieving first to market status with CGT eligibility underscores the collective expertise of our teams and reinforces our focus on delivering dependable supply and value to patients, providers, and the broader healthcare system." — Christine Baeder, President, Apotex Corp. US & LATAM
The approval represents a significant milestone in the collaboration among Apotex, Orbicular, and Gland Pharma. Together, the partners advanced a complex sterile injectable program designed for use in parenteral nutrition, integrating scientific innovation, regulatory strategy, and commercial manufacturing readiness.
As the ANDA applicant, Apotex provided the overarching scientific strategy and regulatory leadership that guided the program and will lead U.S. commercialization. Orbicular supported the development program through end‑to‑end product development activities, including complex emulsion‑based formulation architecture, advanced analytical characterization, and stability and compatibility engineering, culminating in successful DMF adequacy for 13 multivitamins aligned with evolving regulatory expectations. Gland Pharma contributed commercial manufacturing readiness through its sterile injectable infrastructure and execution of exhibit and validation batches.
Dr. Hiren Patel, Chief Executive Officer of Orbicular Pharmaceutical Technologies Pvt. Ltd., said: "Achieving First ANDA approval with CGT designation for a complex formulation integrating 13 vitamins across multiple presentations highlights our ability to convert high scientific complexity into commercially differentiated outcomes. This milestone is the result of nearly a decade of sustained effort, involving multiple development iterations and extensive effort in securing adequacy for 13 DMFs with evolving regulatory requirements. Securing a first approved ANDA position with eligibility for 180-day CGT exclusivity further reinforces the strength of our development model and our ability to translate complex scientific challenges into regulatory and commercial success."
Mr. Srinivas Sadu, Executive Chairman of Gland Pharma Limited, added: "The U.S. FDA approval of the Adult Multiple Vitamin Injection (Single Dose Vials and Pharmacy Bulk Package), along with the grant of 180 days of sole CGT exclusivity for the Pharmacy Bulk Package, marks an important milestone for all partners involved. Gland Pharma is proud to be the manufacturing partner, reflecting our strong sterile injectable capabilities, regulatory expertise, and consistent execution. This approval is the outcome of years of close collaboration and highlights our ability to reliably support complex injectable programs for regulated markets."
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.
Learn more at www.apotex.com
About Orbicular Pharmaceutical Technologies Pvt. Ltd.
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.
About Gland Pharma Limited
Gland Pharma was established in 1978 in Hyderabad and has grown from a contract manufacturer of small‑volume liquid parenteral products to one of the largest and fastest‑growing injectable‑focused companies, with a global footprint across 60 countries. Operating primarily under a B2B model, Gland Pharma has a strong track record in the development, manufacturing, and marketing of sterile injectables, including vials, ampoules, pre‑filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. For more information, visit www.glandpharma.com.
Infuvite® is a registered trademark of Sandoz Canada Inc.
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SOURCE Apotex Corp.
