Drug Approval | September 19, 2024
Lupin receives USFDA approval for Bumetanide Injection
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
Professor G. D. Yadav is one of India’s most prolific and accomplished engineering-scientists, holding the prestigious National Science Chair from the Government of India
Aragen Life Sciences is the first Indian CRDMO to receive SBTi approval
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
This validation aligns with Piramal Pharma's core purpose of 'Doing Well and Doing Good,'
KEYTRUDA is the first and only immunotherapy-based regimen to show a statistically significant and clinically meaningful improvement in overall survival
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices
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