OneSource Strengthens CDMO Play as Partner Secures USFDA Tentative Approval for Ozempic Generic
New Delhi: OneSource Specialty Pharma Limited has announced that its partner Orbicular Pharmaceutical Technologies, along with its U.S.-based front-end partner (the ANDA holder), has secured tentative approval from the U.S. Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for a generic version of Ozempic (semaglutide injection).
OneSource acted as the contract development and manufacturing organization (CDMO) partner for the product, supporting end-to-end manufacturing for the U.S. market filing.
The development marks a significant milestone for the collaboration, highlighting an integrated development-to-submission model. While Orbicular led the product development and technical program for the complex peptide, OneSource provided manufacturing capabilities to support the regulatory filing and future commercial supply.
The company noted that commercial manufacturing is planned from its USFDA-approved flagship facility in Bengaluru, aimed at ensuring reliable supply for the U.S. market.
Commenting on the development, Neeraj Sharma, CEO and Managing Director of OneSource Specialty Pharma Limited, said, “We are pleased to announce that our partner Orbicular, along with its front-end partner, 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 USFDA-approved manufacturing site.”
The company added that the collaboration underscores its growing role as a global CDMO partner in drug-device combinations, complex injectables, and specialty pharmaceutical products, supported by strategic partnerships such as the one with Orbicular.
OneSource is a specialty pharmaceutical CDMO focused on complex product segments, including biologics, sterile injectables, and drug-device combinations. The company operates multiple manufacturing facilities approved by global regulatory authorities and serves international pharmaceutical clients through integrated development and manufacturing solutions.
Orbicular, on the other hand, is a B2B specialty pharmaceutical company engaged in the development of complex generics and specialty products, with capabilities spanning analytical characterization, regulatory strategy, and technology transfer.
The tentative approval indicates that the ANDA meets regulatory requirements but remains subject to final approval, typically linked to patent or exclusivity considerations
