- OneSource Speciality Pharma’s partner Orbicular has received tentative FDA approval for an ANDA for a generic version of Ozempic® (semaglutide injection).
- OneSource acted as the CDMO partner, providing end-to-end contract manufacturing capabilities from its US-FDA approved Bangalore site.
OneSource Speciality Pharma Limited announced that its partner Orbicular Pharmaceutical Technologies, along with its U.S.-based front-end partner, has received 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 supported the program as the contract development and manufacturing organization (CDMO) partner.
The milestone reflects a coordinated development and submission approach. Orbicular led the product development and technical program for the peptide, while OneSource provided end-to-end contract manufacturing capabilities to support the U.S. market filing. Manufacturing and commercial supply are planned from OneSource’s US-FDA approved facility in Bangalore.
“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.”
Mr. Neeraj Sharma, CEO and Managing Director of OneSource Speciality Pharma Limited
The collaboration is designed to enable reliable commercial supply of the product. OneSource stated that its role as a CDMO partner includes supporting manufacturing and readiness for commercialization as part of the ANDA pathway.
