Apotex, in partnership with Orbicular and Gland Pharma, secures FDA approval for generic Infuvite® Adult Injection, gaining 180-day CGT exclusivity for the pharmacy bulk package in the U.S.
Written By: Nikita Jha, BPharm
Reviewed By: Pharmacally Editorial Team
In a coordinated regulatory and manufacturing push, Apotex Corp., in partnership with Orbicular Pharmaceutical Technologies Pvt. Ltd. and Gland Pharma Limited, has received approval from the U.S. Food and Drug Administration for two Abbreviated New Drug Applications (ANDAs) for generic Infuvite® Adult Injection. The approvals cover both Single Dose and Pharmacy Bulk Package presentations, with the latter qualifying for 180-day Competitive Generic Therapy (CGT) exclusivity in the United States.
First-to-Market Position with CGT Exclusivity
The CGT designation for the pharmacy bulk package positions Apotex as the first approved generic entrant in this category, granting a temporary period of market exclusivity. The product is used in parenteral nutrition, supplying essential vitamins for patients requiring intravenous nutritional support.
Partnership Anchored in Technical and Regulatory Execution
The approval marks a milestone in a multi-partner collaboration focused on developing a complex sterile injectable product. The program required integration of formulation science, regulatory strategy, and scalable manufacturing.
Apotex, as the ANDA applicant, led the overall scientific and regulatory strategy and will drive commercialization in the U.S. market. Orbicular handled end-to-end product development, including emulsion-based formulation design, analytical characterization, and stability studies. The company also secured Drug Master File (DMF) adequacy for 13 multivitamin components aligned with evolving regulatory standards. Gland Pharma contributed manufacturing expertise, executing exhibit and validation batches using its sterile injectable infrastructure.
Leadership Perspectives on Milestone Achievement
Christine Baeder, President, Apotex Corp. US & LATAM emphasized that the approval reflects the strength of its partnership model and reinforces its focus on ensuring reliable access to high-quality injectable medicines in the U.S.
Dr. Hiren Patel, Chief Executive Officer of Orbicular highlighted that achieving first ANDA approval with CGT exclusivity for a formulation integrating 13 vitamins demonstrates the company’s ability to translate scientific complexity into commercially viable outcomes. The effort, spanning nearly a decade, involved multiple development iterations and regulatory alignment.
Mr. Srinivas Sadu, Executive Chairman of Gland Pharma Limited noted that the approval underscores the company’s capabilities in sterile manufacturing and regulatory compliance, adding that sustained collaboration among partners was critical to delivering a complex injectable product for regulated markets.
Advancing Access to Complex Injectables
The approval of generic Infuvite® Adult Injection reflects growing industry capability to develop and scale complex injectable formulations. With CGT exclusivity secured for one presentation, the collaboration establishes an early commercial foothold while contributing to supply reliability in parenteral nutrition therapies.
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About the Writer
Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.
