Lupin gets USFDA approval for generic drug

India Pharma Outlook Team | Friday, 23 September 2022

 India Pharma Outlook Team

Drug firm Lupin on said it has received approval from the US health regulator to market a generic non-steroidal anti-inflammatory drug in the American market. The company has received approval from the US Food and Drug Administration for Diclofenac Sodium Topical Solution, Lupin said in a statement. The company's product is a generic equivalent of Horizon Pharma's Pennsaid Topical Solution, it added. The product will be manufactured at Lupin's facility in Pithampur, Madhya Pradesh.

As per IQVIA MAT June 2022 data, Diclofenac Sodium Topical Solution had estimated annual sales of USD 484 million in the US. Shares of Lupin on Thursday ended 0.23 per cent up at Rs 662.70 apiece on the BSE.

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