Orbicular Pharma, Apotex Secure USFDA Tentative Nod for Generic Ozempic

The product will be marketed and commercialised in the United States by Apotex Corp., the Abbreviated New Drug Application (ANDA) applicant, the Hyderabad based pharma company said in a release here.

The tentative approval marks a significant milestone in expanding access to complex peptide-based therapies, which are considered among the most scientifically and regulatorily challenging segments in generic drug development.

Dr. M. S. Mohan, Managing Director of Orbicular Pharmaceutical Technologies, said achieving technical equivalence in complex peptide products requires high scientific precision and disciplined development.

He noted that the collaboration combined Orbicular’s development expertise with Apotex’s regulatory leadership, enabling the partners to secure the FDA’s tentative approval.

Barry Fishman, Chief Corporate Development Officer at Apotex, acknowledged Orbicular’s contribution, stating that the company’s scientific depth and quality focus were instrumental in advancing the programme.

He added that Apotex remains committed to delivering high-quality, affordable peptide therapies and values the partnership that enabled the milestone.