Drug Approval | September 04, 2025
Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension
Rivaroxaban is used to treat venous thromboembolism
The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA
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Marksans Pharma gets USFDA nod for acid reflux drug
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
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