Shares of Strides Pharma were trading almost 4% higher on 21 November after the company announced receiving approval from USFDA (US Food & Drug Administration) for its seizure drug.

The wholly-owned subsidiary of the company, Strides Pharma Global Pte Limited, Singapore, had received approval for its Levetiracetam Oral Solution USP, 100 mg/mL, which is a bio-equivalent and therapeutic equivalent to RLD (Reference Listed Drug) Keppra Oral Solutions, 100mg/mL of UCB, Inc.

The Levetiracetam Oral Solution has a market size of $55 million per year, per the IQVIA data. The drug will be manufactured at the company’s facility in Bengaluru.

The company has approximately 260 ANADs (abbreviated new drug applications) with the USFDA, including the recently acquired portfolio from Endo at Chestnut Ridge. Of these, 230+ ANADs have received final approval from the regulator.

In its regulatory filing, the company said that they have set a target to launch 60 new products in the US over a period of three years.

The product will be manufactured at the company’s facility in Bengaluru. Strides Pharma 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.

In its quarterly report for Q2, the company posted a net loss of Rs 131.3 crore for the quarter under review, compared to the net profit of Rs 22.8 crore it recorded in the same quarter of the previous fiscal year.

At 3:00 pm, the shares of Strides Pharma were trading 1.03% higher at Rs 495.60 on NSE.