Glenmark Pharma introduces Vancomycin Injection in U.S. market

The product is bioequivalent and therapeutically equivalent to the reference listed drug by Fresenius Kabi USA, LLC.

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)

Aurobindo Pharma wins USFDA nod for rare disease drug set for immediate launch

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually

Marksans Pharma receives USFDA approval for Benzonatate capsules

Benzonatate is a non-narcotic antitussive that numbs stretch receptors in the respiratory tract

Alembic receives USFDA final approval for Paroxetine Extended-Release Tablets

Paroxetine extended-release tablets are indicated for the treatment of major depressive disorder

Glenmark Pharmaceuticals USA to launch Potassium Phosphates Injection USP in multiple vial sizes

The product is bioequivalent and therapeutically equivalent to Fresenius Kabi’s reference drug (NDA 212832)