Strides receives USFDA approval for Gabapentin Capsules

Mumbai, Oct 20 (UNI) Pharma Major, Strides Pharma Science Limited said on Saturday that its step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore, has received approval for Gabapentin Capsules USP, 100 mg, 300 mg, and 400 mg from the United States Food & Drug Administration (USFDA). 


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 ‘Generic Drug User Free Amendment’ (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 78 cumulative Abbreviated New Drug Application (ANDA) filings with USFDA of which 53 ANDAs have been approved as of date and 25 are pending approval.