Lupin Limited (LUPIN) secures U.S. FDA approval for Modafinil Tablets, expanding its generics portfolio with a bioequivalent to Provigil®.
Lupin Limited (LUPIN) secures FDA approval for Sodium Zirconium Cyclosilicate Oral Suspension, expanding its therapeutic portfolio.
Dr. Reddy's Laboratories Ltd. (NSE: DRREDDY) receives FDA approval for its rituximab biosimilar, expanding its global biosimilars portfolio.
Lupin Limited (LUPIN) announces U.S. FDA approval and launch of Sugammadex Injection, a bioequivalent to Bridion®.
Alembic Pharmaceuticals Limited (APLLTD) secures USFDA final approval for Prucalopride Tablets, 1 mg and 2 mg, expanding its generic drug portfolio.
Glenmark Pharmaceuticals Limited (GLENMARK) secures U.S. FDA approval to expand RYALTRIS® use for children aged 6 to less than 12 years.
Alembic Pharmaceuticals Limited (APLLTD) announces USFDA final approval for Dapsone Gel, 5%, expanding its generic drug portfolio.
Aurobindo Pharma Limited (AUROPHARMA) secures final approval from US FDA for Tofacitinib Tablets, targeting a US$494 million market.
Wockhardt Limited (WOCKPHARMA) receives U.S. FDA approval for ZAYNICH™, a novel antibiotic for treating complicated urinary tract infections.
Alembic Pharmaceuticals Limited (APLLTD) announced USFDA tentative approval for Darolutamide Tablets, 300 mg, with an estimated market size of US$ 3,155 million.