Strides Pharma subsidiary gets USFDA nod for Oseltamivir Phosphate for Oral Suspension
Bengaluru: Strides Pharma Science Limited has recently 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...
Bengaluru: Strides Pharma Science Limited has recently 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.
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.
The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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 company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval.
Read also: Strides Pharma biotech division gets CDSCO nod to manufacture, export Sputnik Light
Strides 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 (Florida).
Read also: Strides Pharma to buy Endo International New York facility, ANDAs for Rs 178 crore
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd