Apotex Announces FDA Approval of Generic Infuvite® Pediatric Injection, Eligible for 180 day CGT Exclusivity (Single Dose Vial) Complementing its Recent Approval of Generic Infuvite Adult Injection
Apr 27, 2026Weston, Florida – April 27, 2026 — Apotex, in collaboration with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, today announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) for generic Infuvite® Pediatric Injection, which is eligible for 180‑day Competitive Generic Therapy (CGT) exclusivity for single dose vial. Apotex is the ANDA sponsor and will lead commercialization in the United States.
This approval follows Apotex's April 13 announcement of FDA approval for the generic Infuvite® Adult Injection, marking this the second FDA authorization within days for this multivitamin injectable product family. Together, the two approvals represent a coordinated advancement in expanding access to parenteral nutrition options for both adult and pediatric patients.
The Pediatric approval reflects the combined scientific, regulatory, and manufacturing capabilities of Apotex, Orbicular, and Gland Pharma. The program involved complex formulation development, analytical characterization, and sterile injectable manufacturing readiness to support a robust regulatory submission.
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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