Orbicular Pharmaceutical Technologies, in collaboration with Gland Pharma and Apotex, has received approval from the US Food and Drug Administration for a generic version of Infuvite Adult, an injectable formulation used in parenteral nutrition.

The product has been approved through the Abbreviated New Drug Application (ANDA) pathway and granted Competitive Generic Therapy (CGT) designation, marking the first approval in this category with such status. The designation provides a six-month exclusivity period in the US market, reinforcing the strategic advantage of the collaboration.

The approval represents the culmination of nearly nine years of joint development efforts among the three companies. Orbicular led the end-to-end product development, including formulation design, analytical characterisation, stability and compatibility studies and the successful filing of Drug Master Files (DMFs) for 13 vitamins.

Gland Pharma supported the programme by ensuring commercial manufacturing readiness through its sterile injectable infrastructure, while Apotex acted as the ANDA applicant, overseeing regulatory strategy and will lead commercialisation in the United States.

The injectable formulation is a complex, stability-sensitive system integrating 13 vitamins, requiring high precision in formulation, supply chain coordination and regulatory compliance. The successful approval highlights the partners’ ability to navigate scientific and regulatory challenges while delivering a scalable and commercially viable product.

Industry leaders noted that the milestone underscores strong collaboration across development, manufacturing and regulatory functions, positioning the product as a high-value offering with significant barriers to entry in the generics market.