Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries

Zydus receives approval from COFEPRIS to market? Mamitra to treat various cancers

The drug will be marketed in different strengths of 150 mg and 440 mg and used in the treatment of patients with HER2

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials

Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

The product is bioequivalent and therapeutically equivalent to the reference listed drug

Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH

Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India

Alembic receives USFDA’s final approval for Fluphenazine Hydrochloride Tablets