Strides receives USFDA approval for Gabapentin Capsules

Deepthi | Myequity news | Date : 20-10-2018 13:50:00 IST

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 (US FDA). 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.

About Gabapentin Capsules:

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.

About Strides:


Strides is global pharmaceutical Company headquartered in Bangalore. The Company has two business verticals, viz., Regulated Markets and Emerging Markets. The Company has a global manufacturing footprint with 7 manufacturing facilities spread across three continents including 5 facilities for the Regulated Markets and 2 facilities for the Emerging Markets. The Company has strong R&D infrastructure in India with global filing capabilities and a strong commercial footprint across 100 countries.

 


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