OneSource Specialty Pharma has announced that its partner, Orbicular Pharmaceutical Technologies, along with its U.S.-based front-end partner, has secured tentative approval from the U.S. Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic semaglutide injection. OneSource acts as the contract development and manufacturing organisation partner for this product.
Orbicular led the product development and technical program for this complex peptide, while OneSource provided end-to-end manufacturing capabilities for the U.S. market filing as the CDMO partner. This collaboration is designed to ensure a reliable commercial supply from OneSource’s FDA-approved site in Bangalore.
OneSource Specialty Pharma is a speciality pharmaceutical CDMO focused on the development and manufacturing of biologics, drug-device combinations, sterile injectables, and oral technologies across five manufacturing facilities.
Orbicular is a B2B speciality pharmaceutical company that specialises in designing, developing, and delivering complex generics and speciality pharmaceutical products. Orbicular enables its partners to bring high-value, technically complex products to global markets.
Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma, stated that this approval milestone highlights Orbicular’s scientific expertise and OneSource’s CDMO capabilities, backed by an FDA-approved manufacturing site.
He emphasised that this achievement strengthens OneSource’s position as a global CDMO partner for drug-device combinations, complex injectables, and speciality pharmaceutical products. OneSource is committed to supporting manufacturing and ensuring commercial supply readiness.