Strides receives USFDA approval for Gabapentin capsules

Strides Pharma Science Limited has announced that Strides Pharma Global Pte. Limited, Singapore, a step-down wholly-owned subsidiary of Strides has received approval for Gabapentin capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food & Drug Administration (USFDA).
 
Gabapentin is an anticonvulsant or antiepileptic drug used with other medications to prevent and control seizures. Gabapentin capsules is a generic version of Neurontin capsules of Pfizer Inc. The product received approval in the first cycle of review of 10 months under the GDUFA II regime.  

According to IQVIA MAT data, the US market for Gabapentin capsules USP, 100 mg, 300 mg, and 400 mg is approximately US$ 270 mn. The product will be marketed by Strides Pharma Inc. in the US market.  

The company has two business verticals, viz.,regulated markets and emerging markets. It has a global manufacturing footprint with 7 manufacturing facilities spread across three continents. The company has strong R&D infrastructure in India with global filing capabilities and a strong footprint across 100 countries.  

On Friday, the shares of the company closed at Rs 424.35 on the BSE, down by 2.10 per cent. The stock could be in the limelight on Monday’s trading session.