Strides Pharma Science’s step‐down wholly owned subsidiary, Strides Pharma Global Pte, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food and Drug Administration (USFDA). Gabapentin Capsules is a generic version of Neurontin Capsules of Pfizer. The product received approval in the first cycle of review of 10 months under the GDUFA II regime. Gabapentin is an anticonvulsant or antiepileptic drug used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles in adults.
According to IQVIA MAT data, the US market for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg is around $270 million. The product will be marketed by Strides Pharma Inc in the US Market. The company has 78 cumulative ANDA filings with USFDA of which 53 ANDAs have been approved as of date and 25 are pending approval.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.