Strides Shasun's wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received final approval for ketoconazole tablets USP, 200 mg from the US FDA.
Ketoconazole tablets is a generic version of Nizoral tablets, 200 mg, of Janssen Pharmaceuticals, Inc. Ketoconazole tablets 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.
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 Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 75 cumulative ANDA filings with US FDA of which 49 ANDAs have been approved as of date and 26 are pending approval.