“We wish to confirm that the Company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Emtricitabine and Tenofovir Alafenamide Tablets, 200 mg/25 mg, to market a generic equivalent of Descovyยฎ Tablets, 200 mg/25 mg of Gilead Sciences, Inc,” Lupin said in an exchange filing.
The approval allows Lupin to market a generic version of Descovy tablets, a product originally developed by Gilead Sciences Inc. Lupin is one of the first companies to receive approval for this generic formulation, making it eligible for 180 days of shared generic exclusivity in the US market. The product will be manufactured at Lupinโs Nagpur facility in India.
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Lupin noted that the approval was not considered material for disclosure under Regulation 30 of SEBI Listing Regulations at the time. The company emphasized its commitment to prompt and transparent communication for any future material developments.
“Further, the company is not aware of any other event or information that was required to be announced and has not been announced in terms of the SEBI Listing Regulations. The company makes prompt disclosures, as and when any event or information is considered material or warrants such disclosure under the said Regulations and shall continue to do so,” it added.Also Read: Sebi tightens SME IPO rules, limits promoter OFS to 20%On Wednesday, Lupin shares closed at Rs 2,098.7, up 2.6% on the BSE, while the benchmark Sensex declined 0.62%. The stock has gained 60% so far in 2024 and 188% over the past two years, with the companyโs market capitalization now at Rs 95,742 crore.
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