Strides Shasun gets USFDA approval for Ketoconazole Tablets

Strides Shasun announced that its wholly owned subsidiary Strides Pharma Global, has received final approval for Ketoconazole Tablets USP, 200 mg from the United States Food & Drug Administration (US FDA). Ketoconazole Tablets is a generic version of Nizoral Tablets, 200 mg, of Janssen Pharmaceuticals, Inc.

Ketoconazole Tablet is part of the niche and small volume product portfolio with limited competition in the US market. As per IQVIA MAT April 2018 data, the US market for Ketoconazole Tablets was approximately USD 7 Million. The product will be manufactured at the company's Oral dosage facility at Bangalore and will be marketed by Strides Pharma Inc. in the US Market.

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