Strides receives USFDA approval for Oseltamivir Phosphate for Oral Suspension
Strides receives USFDA approval for Oseltamivir Phosphate for Oral Suspension
To be marketed by Strides Pharma Inc. in the US market
Bengaluru, January 17, 2022 – Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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 ~US$ 132 Mn. 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.
About Oseltamivir Phosphate for Oral Suspension
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL is indicated for i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and ii) prophylaxis of influenza A and B in patients 1 year and older.
About Strides
Strides, listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bengaluru, India. The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy along with an institutional business to service donor-funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru), Singapore, Italy (Milan), Kenya (Nairobi) and the United States (New York). The Company focusses on “difficult to manufacture” products that are sold in over 100 countries. Additional information is available at the Company’s website at www.strides.com
