The company's US-based subsidiary, Lupin Pharmaceuticals Inc, has received final approval for the product from the US Food and Drug Administration (USFDA), Lupin said in a statement.
The Mumbai-based company's product is the generic version of Taro Pharmaceuticals Inc's Topicort Ointment.
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As per IMS MAT September 2016 sales data, Topicort had US sales of USD 14.4 million.
Shares of Lupin today ended at Rs 1,528.05 apiece on the BSE, down 0.56 per cent from previous close.