Strides Pharma Science’s (Strides) step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tamiflu for Oral Suspension, 6 mg/mL, of Hoffmann-La Roche, Inc.
According to IQVIA MAT November 2020 data, the US market for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL was approximately around $132 million. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 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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