Apotex in partnership with Orbicular Pharmaceutical and Gland Pharma announced that the 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."
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