Strides Shasun announced that it's wholly owned subsidiary Strides Pharma Global has received approval for Efavirenz Tablets USP, 600 mg from the United States Food & Drug Administration (US FDA). Efavirenz Tablet is generic version of Sustiva Tablets of Bristol-Myers Squibb Company.
According to IQVIA data, the US market for Efavirenz Tablets USP, 600 mg is approximately USD 115 Million and Strides is only the second generic company to get the approval for the product under the para IV route. 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. Strides is launching the product immediately.
The company has 74 cumulative ANDA filings with USFDA of which 44 ANDAs have been approved as of date and 30 are pending approval.
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