Orbicular Partner Secures Tentative U.S. FDA Approval for Generic Semaglutide Injection
Bangalore, April 21, 2026 OneSource Specialty Pharma Limited announced that its partner, Orbicular Pharmaceutical Technologies, 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) covering a generic version of Ozempic (Semaglutide Injection). OneSource serves as the contract development and manufacturing organization (CDMO) partner for this critical product.The achievement highlights a deeply integrated development and submission model. Orbicular spearheaded the product development and technical program for this complex peptide, while OneSource provided comprehensive support as the CDMO partner, facilitating end-to-end manufacturing capabilities necessary for the U.S. market filing. The collaboration is intended to guarantee reliable commercial supply, utilizing OneSource's US-FDA approved flagship site located in Bangalore.
Neeraj Sharma, CEO & MD of OneSource Speciality Pharma Limited, commented on the development, stating, "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 bolster its standing as a global CDMO partner for specialized products, including complex injectables, drug-device combinations, and specialty pharmaceuticals. The partnership with Orbicular exemplifies this strategy, positioning OneSource to support manufacturing and commercial supply readiness.
Company Profiles
About OneSource Specialty Pharma LimitedOneSource Specialty Pharma Limited is a specialized, pure-play CDMO focused on the development and manufacturing of complex pharmaceutical products. Its portfolio includes biologics, drug-device combinations, sterile injectables, and oral technologies (soft gelatin capsules). The company operates five state-of-the-art manufacturing facilities approved by global regulatory authorities and employs over 1,600 professionals. With its robust development capabilities, industry-leading manufacturing capacities, and strong compliance track record, OneSource serves global pharmaceutical companies seeking efficient, end-to-end solutions.
About Orbicular
Orbicular is a B2B specialty pharmaceutical company dedicated to designing, developing, and delivering complex generics and specialty pharmaceutical products. By integrating capabilities across development, advanced analytical characterization, regulatory strategy, and technology transfer, Orbicular enables its partners to introduce high-value, technically complex products into global markets.
ONESOURCE Stock Price Movement
On Monday, Onesource Specialty Pharma Limited shares edged higher, gaining 0.10% to close at ₹1549.2. The stock settled at the close on high volume, with 496,106 shares traded throughout the session.Source:
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