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Pharma major Lupin Ltd on Tuesday said it has received tentative approval from the US health regulator for its generic version of Sugammadex injection used for reversing the effects of muscle relaxants given during surgery. The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial, Lupin said in a regulatory filing. The USFDA has tentatively approved Lupin's Sugammadex injection of the specified strengths as bioequivalent to Merck's Bridion injection, it added. It is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.
Drug maker Lupin on Wednesday said its subsidiary, Lupin Atlantis Holdings SA (LAHSA), has inked a licence and supply agreement with Galenicum Health for diabetes and weight management medication. Lupin Atlantis Holdings SA (LAHSA) has entered into a partnership with Galenicum for finished formulations of injectable Semaglutide, a GLP-1 receptor agonist. As per the agreement, Galenicum will oversee development, manufacturing, and supply, while Lupin will handle regulatory submissions, approvals, and the commercialisation and distribution of Semaglutide across 23 countries globally, including Canada, Europe, Southeast Asia, and Latin America, the Mumbai-based drug maker said in a statement. "Our partnership with Galenicum marks a strategic milestone in strengthening Lupin's Semaglutide portfolio. As diabetes continues to escalate globally and obesity emerges as a major global health priority, Semaglutide stands out as a critical therapy," said Fabrice Egros, President, Corporate ...