 "Strides Pharma")
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Strides Pharma Science Limited (Strides) has received approval of Gabapentin Tablets USP, in strengths of 600 mg and 800 mg, by the United States Food & Drug Administration (USFDA). This announcement is a step towards expanding Strides' product portfolio and catering to the needs of patients suffering from neurological conditions. The approval granted to Strides Pharma Global Pte Limited, Singapore, was announced through a release on the exchanges.
Gabapentin is an anticonvulsant medication that is primarily prescribed for the treatment of partial seizures and neuropathic pain. It is widely used in managing neuropathic pain associated with diabetic neuropathy, postherpetic neuralgia, and central pain. In this regard, Gabapentin serves as a vital therapeutic option for patients seeking relief from these debilitating conditions.
The approval also complements Strides' existing approval for Gabapentin capsules, which already commands a market size of $208 million. The newly approved Gabapentin tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, 600 mg and 800 mg, marketed by Viatris Specialty LLC, which comes with a market size estimated at around $140 million according to IMS data.
Strides Pharma boasts 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA, including the recently acquired portfolio from Endo at Chestnut Ridge. Of these, more than 235 ANDAs have received approval. The company has set targets to launch approximately 60 new products in the US market over the next three years.
The pharmaceutical company is headquartered in Bengaluru, India, with manufacturing facilities spanning across India, Singapore, Italy, Kenya, and the United States of America. Manufacturing of the Gabapentin tablets will be carried out at Strides' facility located in Puducherry, India.
