Hyderabad firm’s Ozempic generic gets USFDA nod

Hyderabad-based Orbicular Pharmaceutical Technologies announced that its generic version of Ozempic (semaglutide injection), developed with Apotex, has received tentative approval from the USFDA. The drug will be marketed in the United States by Apotex Corp.

Hyderabad: Orbicular Pharmaceutical Technologies Pvt Ltd, a Hyderabad-based developer of complex peptide-based generics, announced that a generic version of Ozempic (semaglutide injection), developed in partnership with Apotex, has received Tentative Approval from the US Food and Drug Administration (FDA).

The product will be marketed and commercialised in the United States by Apotex Corp., the ANDA applicant. The Tentative Approval represents a significant milestone in advancing access to complex peptide therapies, an area where scientific, analytical, and regulatory challenges are among the most demanding in generic drug development.

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Dr M S Mohan, Managing Director, Orbicular Pharmaceutical Technologies, said, “Achieving technical equivalence for complex peptide products requires deep scientific rigor, advanced analytical precision, and a highly disciplined development approach.”

Barry Fishman, Chief Corporate Development Officer, Apotex, added, “Orbicular’s scientific depth and commitment to quality were instrumental in supporting this complex programme.”