OneSource Specialty Pharma’s partner Orbicular Pharmaceutical Technologies (Orbicular), together with its U.S.-based front-end partner (the ANDA holder), has secured tentative U.S. Food and Drug Administration (FDA) approval for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic (Semaglutide Injection). The company is the contract development and manufacturing organization (CDMO) partner for this product.
This step highlights a closely integrated development-to-submission model: Orbicular led the product development and technical program for this complex peptide, while the company supported the program as the CDMO partner, providing end-to-end manufacturing capabilities for the U.S. market filing. The collaboration is designed to ensure reliable commercial supply from the company’s US-FDA approved flagship site in Bangalore.
OneSource Specialty Pharma is a multimodal specialty pharma CDMO with end-to-end capabilities across technology platforms and therapeutic modalities.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1876.40 |
| Dr. Reddys Labs. | 1180.50 |
| Cipla | 1431.85 |
| Lupin | 2225.00 |
| Zydus Lifesciences | 1117.00 |
| View more.. | |
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