INDIA – Strides Pharma Global Pte. Ltd (SPG), the international headquarters for Strides Pharma Science Limited, has scored approval from the United States Food and Drug Administration (U.S. FDA) for its generic drug for seizures.
The generic product will be manufactured at the Strides Pharma Science Limited’s facility in Bengaluru, the southern Indian state of Karnataka.
In a regulatory filing, the company said: “Strides Pharma Global Pte Ltd has received approval for Levetiracetam Oral Solution USP, 100 mg/mL, from the FDA.”
Following the authorization from the FDA, Strides Pharma Global Pte. Ltd now has 260 cumulative abbreviated new drug application (ANDA) filings with the FDA.
This FDA approval comes at a time when SPG has set a target to launch 60 new products over three years in the United States of America.
Currently, the Singapore-based company has over 230 filings that have been approved by the United States Food and Drug Administration.
The company manufactures pharmaceutical products, over-the-counter drugs and nutraceuticals. Products include soft gel capsules, hard-gel capsules, tablets and dry and wet injectables.
SPG is a subsidiary of Strides Pharma Science Limited, an Indian pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations.
With world-class manufacturing facilities, Strides Pharma Science Limited has earned a reputation for building and scaling profitable businesses in a short span of time.
The company runs an innovative Research & Development (R&D) hub in Bangalore and a robust commercial platform to market products globally.
Strides Pharma Science Limited’s subsidiary has received approval from the US health regulator to market a generic medication for seizures.
According to recently published data by IQVIA, formerly Quintiles and IMS Health, Inc., the Levetiracetam Oral Solution has a market size of US$55 million.
On the FDA clearance, Strides Pharma said: “The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Keppra Oral Solution of UCB, Inc.”