Osimertinib works by slowing or stopping the growth of cancer cells and binds to a certain protein (epidermal growth factor receptor-EGFR) in some tumors
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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
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 Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
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