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Lupin receives USFDA approval for new drug

The product will be manufactured at Lupin’s facility in Pithampur, India.

September 23, 2022 9:18 IST | India Infoline News Service
Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Diclofenac Sodium Topical Solution USP, 2% w/w.

The approval is to market a generic equivalent of Pennsaid Topical Solution, 2% w/w of Horizon Pharma Ireland DAC and the product will be manufactured at Lupin’s facility located in Pithampur, India.

According to the IQVIA MAT June 2022 data, Diclofenac Sodium Topical Solution USP, 2% w/w (RLD Pennsaid) had estimated annual sales of USD 484 million in the U.S.

At around 9:18 AM, Lupin Ltd is currently trading at Rs664.80 per share up by Rs1.55 or 0.23% from its previous closing of Rs663.25 per share on the BSE.

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