Latest news with #USFoodandAdministration
Business Standard
08-05-2025
- Business
- Business Standard
Lupin gets USFDA nod for Raltegravir tablets
Lupin announced that it has received an approval from US Food and Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg. Raltegravir Tablets are bioequivalent to Isentress HD Tablets, 600 mg, of Merck Sharp & Dohme LLC. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. The product will be manufactured at Lupins Nagpur facility in India. Raltegravir Tablets USP, 600 mg, are indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult patients and pediatric patients weighing at least 40 kg. Raltegravir Tablets USP, 600 mg (Reference Listed Drug: Isentress HD), had estimated annual sales of $34 million in the U.S. for the 12 months ending March 2025, according to IQVIA. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025. The scrip fell 3.12% to end at Rs 2,006.40 on the BSE.
Business Standard
08-05-2025
- Business
- Business Standard
Lupin gets USFDA nod for Eslicarbazepine Acetate tablets
Lupin announced that it has received an approval from US Food and Administration (USFDA) for Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg. The company is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg are bioequivalent to Aptiom Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, of Sumitomo Pharma America, Inc., and indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As per IQVIA MAT March 2025, Eslicarbazepine Acetate Tablets had estimated annual sales of $395 million in the U.S. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit jumped 39.5% to Rs 855.16 crore in Q3 FY25 as compared with Rs 613.12 crore in Q4 FY24. Net sales increased 10.6% YoY to Rs 5618.56 crore during the quarter ended 31st March 2025. The scrip advanced 1.08% to end at Rs 2,070.95 on Wednesday, 7 May 2025.
