The approval granted to the company’s step-down wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, by the US Food and Drug Administration (USFDA) is for Ibuprofen oral suspension of the strength of 100 mg/5 ml, the company said in a statement.
PTI
May 30, 2022 / 02:39 PM IST
Representative image
Strides Pharma Science Ltd (Strides) on Monday said its Singapore-based arm has received approval from the US health regulator for generic Ibuprofen oral suspension, which is used to relieve pain from various conditions.
The approval granted to the company’s step-down wholly-owned subsidiary Strides Pharma Global Pte Ltd, Singapore, by the US Food and Drug Administration (USFDA) is for Ibuprofen oral suspension of the strength of 100 mg/5 ml, the company said in a statement.
The product is bioequivalent and therapeutically equivalent to the reference listed drug Motrin oral suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil), it added.
The product will be manufactured at the company’s facility in Bengaluru and will be marketed by Strides Pharma Inc in the US market.
Citing IQVIA MAT March 2022 data, the company said the US market for Ibuprofen oral suspension 100 mg/5 ml is approximately USD 66 million.
Strides said it has a total of 274 abbreviated new drug application (ANDA) filings with USFDA, of which 250 ANDAs have been approved and 24 are pending approval.
It currently has around 60 commercialised products in the US and has set a target to launch around 20 new products every year from the combined portfolio, Strides noted.
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