Alembic Pharma receives USFDA tentative approval for Binimetinib tablets

Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market

Alembic Pharma receives USFDA tentative approval for generic Larotrectinib capsules

Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.

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

Lupin receives FDA’s tentative approval for Sugammadex injection

Sugammadex injection is bioequivalent to Merck’s Bridion injection for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery

Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration

Alembic announces USFDA tentative approval for Bosutinib tablets

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia

Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis