In a BSE filing, Shasun Pharmaceuticals said, "It has received approval from the United States Food and Drug Administration (US FDA) for Carisoprodol tablets."
The approval is for the 250 mg and 350 mg strengths.
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Shasun Pharma said Carisoprodol tablets of 250 mg and 350 mg have sales of approximately $38 million.
"While the 350 mg has a few generic players, Shasun expects to be the first marketed generic player in the $16 million Carisoprodol tablets of 250 mg opportunity," it added.
Shasun Pharmaceuticals said the product will be manufactured at its Puducherry plant and distributed through a partner. It's expected to be launched shortly.
The stock of Shasun Pharmaceuticals was trading at Rs 404.60 on BSE, up 1.67%, from its previous close.