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Strides Shasun gets USFDA approval for Efavirenz Tablets

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announced that it's wholly owned subsidiary Global has received approval for Tablets USP, 600 mg from the Food & Drug Administration (US FDA). Tablet is generic version of Sustiva Tablets of Company.

According to IQVIA data, the US market for 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 and will be marketed by 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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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Wed, March 14 2018. 09:21 IST