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Strides Shasun gets US FDA nod for generic Tamiflu capsules
Our Bureau, Mumbai | Tuesday, June 12, 2018, 12:10 Hrs  [IST]

Strides Shasun has announced that it’s wholly owned subsidiary Strides Pharma Global Pte. Ltd. has received final approval for oseltamivir phosphate capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base)  from the United States Food & Drug Administration (FDA).

Oseltamivir phosphate capsules is a generic version of Tamiflu capsules of Hoffmann-La Roche, Inc. Oseltamivir phosphate capsules registered a significant volume growth due to one of  the worst flu seasons in the US last year.

As per IQVIA MAT April 2018 data, the US market for oseltamivir phosphate capsules was approximately USD 725 million. The product will be manufactured at the company’s oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Oseltamivir phosphate capsule is prescribed to treat symptoms caused by the flu virus (influenza). It helps make the symptoms such as stuffy nose, cough, sore throat, fever/ chills, aches, and tiredness less severe and shortens the recovery time.

The company has 75 cumulative ANDA filings with US FDA of which 48 ANDAs have been approved as of date and 27 are pending approval.

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