Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market
The approval clears the company to market a generic version that is therapeutically equivalent to Retin-A Cream
Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
US formulations grew 11% to Rs. 564 crore as Alembic enters US branded pharmaceuticals market with launch of Pivya
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
The company reported a 108% rise in profit after tax, driven by strong growth in regulated markets, branded generics, and U.S. expansion initiatives
U.S. business drives strong growth as Lupin reports 57% rise in Q4 U.S. sales and 43% increase in gross profit
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation
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