This sBLA submission is supported by clinical, pre-clinical, and manufacturing data demonstrating the safety, tolerability, and immunogenicity of the bivalent vaccine.
The marketing authorisations for three generic drugs signifying advances in cancer treatment will considerably benefit thousands of patients by improving access, ensuring affordability
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
Themis will market this drug with the brand name REMITHEM.
Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
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