Strides Pharma gains on USFDA nod for Gabapentin tablets

Strides Pharma Science advanced 2.68% to Rs 817.90 after its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Singapore received approval from the United States Food & Drug Administration (USFDA) for Gabapentin tablets.

The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Neurontin tablets of Viatris Specialty LLC.

Gabapentin is an anticonvulsant medication primarily used to treat partial seizures and neuropathic pain. It is a commonly used medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain.

As per IMS, Gabapentin tablets have a market size of around $140 million. 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 product will be manufactured at the companys facility in Puducherry. the company stated.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which over 235 ANDAs have been approved.

The firm said that it has set a target to launch around 60 new products over three years in the US.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

The firm reported consolidated net profit of Rs 49.67 crore in Q3 FY24 as against a net loss of Rs 80.03 crore posted in Q3 FY23. The company recorded quarterly sales of Rs 1,038.9 crore in Q3 FY24, registering a growth of 19.60% from Rs 868.6 crore in Q3 FY23.

Powered by Capital Market - Live News