Orbicular, Gland Pharma and Apotex secure US FDA approval for generic INFUVITE ADULT injectable

Orbicular Pharmaceutical Technologies, Gland Pharma, in partnership with Apotex Inc., announced the approval of a generic INFUVITE ADULT injectable for use in parenteral nutrition.

The product has received Abbreviated New Drug Application approval with Competitive Generic Therapy designation, with Apotex serving as the ANDA applicant and commercialisation partner for the United States.

This approval represents the first ANDA approval for this product category with CGT designation. The milestone establishes a first generic position with six-month exclusivity.

The programme represents a nine-year collaboration between Orbicular, Gland Pharma, and Apotex, involving scientific investment, development iterations, and coordination across the value chain.

Orbicular led the end-to-end product development, including formulation architecture, analytical characterisation, stability and compatibility engineering, and Drug Master File adequacy for 13 multivitamins aligned with regulatory requirements.

Gland Pharma enabled manufacturing readiness through its sterile injectable infrastructure and execution of exhibit and validation batches.

Apotex, as the ANDA applicant, led the regulatory submission and approval strategy and will drive commercialisation in the United States.

The programme involved a multi-component injectable system integrating 13 vitamins across multiple presentations, requiring formulation precision, supply chain coordination, and regulatory alignment, including the filing and maintenance of 13 Drug Master Files through global partnerships.

This has resulted in a product with scalability and commercial validation, with barriers to entry and positioning linked to first-generic exclusivity.

Dr Hiren Patel, Chief Executive Officer of Orbicular Pharmaceutical Technologies Pvt. Ltd., said; “Achieving First ANDA approval with CGT designation for a complex emulsion system 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 generic position with 6-month exclusivity further reinforces the strength of our development model and our ability to translate complex scientific challenges into regulatory and commercial success.”

Srinivas Sadu, Executive Chairman of Gland Pharma Limited, added; “The U.S. FDA approval of the Multiple Vitamin Injection, along with the grant of 180 days of sole CGT exclusivity, 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.”