Lupin receives USFDA approval for Prucalopride Tablets

Prucalopride Tablets are indicated for the treatment of chronic idiopathic constipation in adults

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)

Lupin receives USFDA approval for Rivaroxaban Tablets

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease

Lupin launches Eslicarbazepine Acetate tablets in US

Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity

Innoxel Lifesciences completes USFDA inspection

This outcome reflects Innoxel Lifesciences' ongoing commitment to maintaining the highest standards of quality, compliance, and regulatory excellence

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara

Lupin receives EIR from USFDA for its Somerset manufacturing facility

the inspection conducted from January 27 to January 31, 2025