Biocon inaugurates first US manufacturing facility in New Jersey

Zydus and Synthon ink licensing and supply agreement for Ozanimod Capsules for US market

Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product

CapVest to acquire majority stake in STADA

Bain Capital and Cinven will each retain a minority stake, reflecting their ongoing confidence in STADA’s future growth

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

iPHEX 2025: Global regulatory conclaves to highlight India’s role in shaping global health

This year’s edition will witness participation of over 700 Indian exporters showcasing their products and services; 500+ overseas delegates representing more than 120 countries; 20,000 domestic visitors; and 8,000+ B2B meetings

Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection

Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai

FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug

Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

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

NATCO launches Bosentan Tablets for oral suspension in US with 180-day exclusivity

NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity