Lupin share price was trading higher in the opening trade on May 9 after the company received United States Food and Drug Administration (USFDA) approval for Raltegravir Tablets.
At 09:41am, Lupin was quoting at Rs 2,019.05, up Rs 5.25, or 0.26 percent, on the BSE.
" .... has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Raltegravir Tablets USP, 600 mg," company said in its press release.
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.
This product will be manufactured at Lupin’s Nagpur facility in India.
Raltegravir Tablets USP, 600 mg are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients and in pediatric patients weighing at least 40 kg.
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On May 7, the global pharma major launched Eslicarbazepine Acetate Tablets, 200 mg, 400 mg, 600 mg, and 800 mg, following the approval of its ANDA from the US FDA.
Lupin 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.
A meeting of the board of directors of the company is scheduled to be held on Wednesday, May 14, 2025, to consider and approve the audited standalone and consolidated financial results of the company for the quarter and year ended March 31, 2025 and recommend dividend, if any.
Recently, the pharma stocks remained under pressure after President Trump signed an Executive Order to promote domestic drug manufacturing facilities.
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