Strides Pharma arm obtains USFDA nod for Levetiracetam oral solution

Pharmaceutical firm Strides Pharma Science on Tuesday said that its step‐down wholly owned subsidiary, Strides Pharma Global Private Limited, Singapore, has received approval from the United States Food & Drug Administration (USFDA) for Levetiracetam Oral Solution USP, 100 mg/mL. The product is used for treating seizures.

The company said in a media release that the product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Keppra Oral Solution, 100 mg/mL of UCB, Inc. According to market research firm IQVIA, the Levetiracetam oral solution has a market size of $55 million. It will be produced at the company's facility in Bengaluru.

Strides said that the firm has set a target to launch 60 new products over three years in the US. It has 260 cumulative abbreviated new drug application (ANDA )filings with the FDA, of which 230+ ANDAs have been approved.

In September, Strides said that it is spinning off its contract development and manufacturing (CDMO) business along with the soft-gelatin unit into an entity called 'OneSource' (currently Stelis Biopharma). It is set to be listed in the next 12-15 months to have better synergies and unlock value.

Strides is a global pharmaceutical company with its headquarters in Bengaluru, India. The company's global manufacturing sites are located in India, Singapore, Italy, Kenya, and the United States of America.