Strides Pharma Science secures FDA approval for Gabapentin tablets

In a notable advancement for neuropathic pain treatment, Strides Pharma Science Limited (Strides) has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received the United States Food & Drug Administration (USFDA) approval for Gabapentin Tablets USP, 600 mg and 800 mg. This approval marks a significant milestone for Strides, highlighting its commitment to enhancing healthcare through innovative pharmaceutical solutions.

Gabapentin Tablets, now approved for production, are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Neurontin Tablets, of Viatris Specialty LLC. The approval of these tablets, which have a market size of approximately US$140 million as per IMS data, complements Strides’ existing Gabapentin portfolio. This includes Gabapentin capsules, boasting a market size of US$208 million, and underscores the company’s growing influence in the treatment of neuropathic pain.

Manufacturing of the Gabapentin tablets will take place at Strides’ facility in Puducherry, leveraging state-of-the-art manufacturing practices to ensure high-quality pharmaceutical products. This development is part of Strides’ extensive engagement with the US pharmaceutical market, as evidenced by its 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA. Of these, over 235 ANDAs have been approved, demonstrating the company’s rigorous commitment to meeting stringent regulatory standards and its strategic focus on expanding its product portfolio.

Strides has set an ambitious target to launch approximately 60 new products in the US over the next three years, a plan that reflects its dedication to innovation and its role in addressing critical healthcare needs. Gabapentin, the anticonvulsant medication at the center of this approval, is primarily used to treat partial seizures and neuropathic pain, including conditions caused by diabetic neuropathy, postherpetic neuralgia, and central pain.

The FDA approval of Gabapentin Tablets for Strides Pharma Science Limited represents a noteworthy advancement in the treatment options available for neuropathic pain, a condition that affects millions globally. This approval not only reinforces Strides’ position in the pharmaceutical industry but also highlights the importance of continuous innovation and regulatory compliance in bringing effective treatments to market. As Strides expands its gabapentin portfolio, it contributes significantly to the global effort to manage and treat neuropathic pain, enhancing the quality of life for patients worldwide.