Strides Pharma's arm gets USFDA's nod for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

15 Jan 2021 Evaluate

Strides Pharma Science’s (Strides’) step-down wholly owned subsidiary -- Strides Pharma Global, Singapore, has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.

The company has 127 cumulative ANDA filings with USFDA of which 95 ANDAs have been approved and 32 are pending approval.

Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.

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