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.
Aragen Life Sciences is the first Indian CRDMO to receive SBTi approval
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
The company will now seek final approval from NCLT, Mumbai Bench, and upon its receipt, OneSource will proceed to seek listing approvals from the BSE and NSE
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug
The approval further adds to Biocon’s portfolio of complex drug products
Also received tentative approval for 137 mg
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
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