Strides Shasun’s 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.
Ketoconazole belongs to the class of drugs called azole antifungals. Ketoconazole is used to treat certain serious fungal infections in the body and it works by stopping the growth of the fungus.
As per IQVIA MAT April 2018 data, the US market for Ketoconazole Tablets was approximately $7 million. The product will be manufactured at the company’s Oral dosage facility at Bangalore and will be marketed by Strides Pharma in the US Market.
Strides Shasun is a vertically integrated global pharmaceutical Company headquartered in Bangalore. The company has 74 cumulative ANDA filings with USFDA of which 47 ANDAs have been approved as of date and 27 are pending approval.
