Strides Pharma Science Limited (Strides) on Tuesday announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the United States Food & Drug Administration (USFDA), the company announced through an exchange filing.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. It is used in the treatment of seizures.
The Levetiracetam Oral Solution has a market size of ~US$55 Mn per IQVIA. The product will be manufactured at the company’s facility in Bengaluru.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 230+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.
Strides Pharma Science Limited shares
The shares of Strides Pharma Science Limited on Tuesday at 11:04 am IST were at Rs 507.65, up by 3.49 percent.