Tentative FDA Approval for Generic Ozempic by OneSource Partner
ONESOURCE's partner receives USFDA tentative approval for Semaglutide Injection
Business Standard
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OneSource Specialty Pharma's partner, Orbicular Pharmaceutical Technologies, has received tentative approval from the U.S. Food and Drug Administration (FDA) for a generic version of Ozempic (Semaglutide Injection). This approval is a significant milestone in the collaboration, showcasing integrated development and manufacturing capabilities.
- 01Orbicular Pharmaceutical Technologies received tentative FDA approval for a generic Ozempic.
- 02OneSource Specialty Pharma acts as the contract development and manufacturing organization (CDMO) for this product.
- 03The collaboration ensures reliable supply from OneSource's FDA-approved facility in Bangalore.
- 04This approval highlights Orbicular's scientific expertise and OneSource's manufacturing capabilities.
- 05The development process involved a close partnership between Orbicular and OneSource.
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OneSource Specialty Pharma announced that its partner, Orbicular Pharmaceutical Technologies, has achieved 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). This milestone underscores the effective collaboration between Orbicular and OneSource, with Orbicular leading the product development and technical program for this complex peptide. OneSource, serving as the contract development and manufacturing organization (CDMO), provided comprehensive manufacturing support for the U.S. market filing. The partnership aims to ensure a consistent commercial supply from OneSource's FDA-approved manufacturing site located in Bangalore, India. Neeraj Sharma, CEO and Managing Director of OneSource, expressed satisfaction with the approval, emphasizing the strengths of both companies in achieving this significant milestone.
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The tentative approval could lead to increased availability of a more affordable generic version of Ozempic for patients with type 2 diabetes, potentially lowering treatment costs.
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