Drug Approval | April 28, 2025
CuraTeQ Biologics receives positive opinion for biosimilar Dazublys from EMA
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein
Dasatinib Tablets is indicated for the treatment of (i) newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia
This termination of Agreement will not have any significant impact on the company and/or its subsidiaries or its financials
During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.
Dyrupeg will be available as 6 mg solution for injection in prefilled syringe and is intended for the reduction in the duration of neutropenia
Bevqolva 25 mg/mL concentrate for infusion will be available in 4 mL (100 mg) and 16 mL (400 mg) single-use vials for infusion into veins
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells
The approved product has an estimated market size of US$ 106 million for the twelve months ending October 2024, according to IQVIA
He did Master’s of Pharmacy (Pharmaceutical Technology, Formulations) from National Institute of Pharmaceutical Education and Research, Mohali and Bachelor of Pharmacy from Osmania University
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
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