A generic version of Ozempic (semaglutide injection) developed by Hyderabad-based Orbicular Pharmaceutical Technologies in partnership with Florida-headquartered Apotex Corp. has received tentative approval from the U.S. Food and Drug Administration (FDA).

The product will be marketed and commercialised in the U.S. by Apotex, which is the ANDA applicant, complex peptide-based generics developer Orbicular said in a release.

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Managing Director M.S.Mohan said Apotex’s regulatory leadership combined with Orbicular’s development and execution capabilities has been central to securing the FDA tentative approval.”

“We value this strong partnership, which has enabled us to reach this important milestone,” said Barry Fishman, Chief Corporate Development Officer of Apotex Corp., which is an affiliate of Canadian pharma major Apotex Inc.

Semaglutide is the active ingredient in Danish major Novo Nordisk’s blockbuster diabetes and weight loss drugs, Wegovy and Ozempic. Semaglutide patent expiry in India last month saw a clutch of generic drug makers launching their versions, in the country.