Strides Shasun Limited has said that its wholly owned subsidiary Strides Pharma Global Pte. Ltd. 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. The company has 75 cumulative ANDA filings with USFDA of which 49 ANDAs have been approved as of date and 26 are pending approval. Meanwhile, shares of the company were trading at Rs 415.80 apiece, up 2.70 per cent from the previous close at 09:29 hours on BSE.
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