Orbicular's Partner secures tentative U.S. ANDA approval for a generic version of Semaglutide Injection, supported by OneSource as CDMO partner

OneSource Speciality Pharma Limited (BSE: 544292, NSE: ONESOURCE) today announced that its 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). OneSource is the contract development and manufacturing organization (CDMO) partner for this product.

This milestone highlights a closely integrated development-to-submission model: Orbicular led the product development and technical program for this complex peptide, while OneSource 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 OneSource's US-FDA approved flagship site in Bangalore.

Mr. Neeraj Sharma, CEO & MD, OneSource Speciality Pharma Limited, speaking on the development, said: "We are pleased to announce that our partner Orbicular, along with its front-end partner (the ANDA holder), has received tentative approval for a generic version of Ozempic® (Semaglutide Injection). This milestone reflects Orbicular's scientific expertise and OneSource's CDMO capabilities, supported by our US-FDA approved manufacturing site."

OneSource continues to strengthen its position as a global CDMO partner for drug-device combinations, complex injectables and specialty pharmaceutical products through strategic collaborations such as the one with Orbicular, where OneSource serves as the CDMO partner supporting manufacturing and commercial supply readiness.

Shares of Onesource Specialty Pharma Limited was last trading in BSE at Rs. 1547.85 as compared to the previous close of Rs. 1540.35. The total number of shares traded during the day was 9909 in over 1176 trades.

The stock hit an intraday high of Rs. 1554.00 and intraday low of 1504.45. The net turnover during the day was Rs. 15175088.00.

Source : Equity Bulls

Keywords

OnesourceSpecialtyPharma INE013P01021 OrbicularPharmaceuticalTechnologies TentativeApproval USFDA ANDA SemaglutideInjection