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Pavan Rawat

7th Sep · SEBI-Registered Analyst

LUPIN IN FOCUS POST MODAFINIL TABLETS APPROVAL FROM USFDA

LUPIN
Lupin shares are likely to remain in focus on September 7 after the pharmaceutical company received approval from the United States Food and Drug Administration (USFDA) for its generic drug used to improve wakefulness in adults with excessive sleepiness. The company announced that it received USFDA approval for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. The approved tablets have been determined to be bioequivalent to the reference listed drug (RLD), Provigil Tablets, marketed by Nuvo Pharmaceuticals (Ireland) DAC. Modafinil is indicated to improve wakefulness in adult patients experiencing excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). In August, Lupin's subsidiary VISUfarma B.V. entered into an exclusive licensing agreement with Visus Therapeutics, a subsidiary of Tenpoint Therapeutics, to commercialise, market, promote, distribute and sell YUVEZZI. Lupin shares touched a 52-week high of ₹2,530, and a 52-week low of ₹1,900.30. The stock is currently trading 16.56% below its 52-week high and 11.09% above its 52-week low. The company's market capitalisation stands at approximately ₹96,528.82 crore.

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