Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Gabapentin Tablets USP, 600 mg and 800 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.
Gabapentin tablets has a market size of ~$140 million as per IMS. This approval further strengthens the Company’s presence in the Gabapentin portfolio, complementing the existing approval of Gabapentin capsules, which has a market size of $208 million. The Gabapentin tablets will be manufactured at the company’s facility in Puducherry.
The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 235+ ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.