Drug Approval | April 21, 2026
Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection
The partnership will commercialize four nasal sprays with a combined Global IQVIA market size in excess of $400m
The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval
Approval marks the second generic semaglutide clearance in Canada and strengthens OneSource’s position in complex injectable CDMO programs
Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing
The Product is expected to be the first generic approval on the market
This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
The amalgamation will integrate business operations and provide impetus to the existing portfolio of Alembic
The ANDA has been co-developed in partnership with Orbicular Pharmaceutical Technologies
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