 "Strides Pharma")
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.
