Alembic Pharma gets approval for neuropathic pain capsule

Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for the company’s Abbreviated New Drug Application (ANDA) Pregabalin Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.

The newly approved ANDA is used for managing neuropathic pain which is related to diabetic peripheral neuropathy, managing the postherpetic neuralgia, also as adjunctive therapy for the treatment of partial-onset seizures in patients whose age is 17 years or more, managing of fibromyalgia and managing of neuropathic pain caused due to spinal cord injury. According to IQVIA, the capsules have been estimated to have a market size of US$5.47 billion for the year ended December 2018. Alembic had previously received tentative approval for this ANDA. Pregabalin Capsules is similar and equivalent to a reference listed drug (RLD), Lyrica Capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg, of PF Prism CV.

Almebic Pharmaceuticals Limited is a pharma company which is involved in manufacturing and marketing generic pharmaceutical products. Till now the company has a total of 98 ANDA approvals which include 88 final approvals and 10 tentative approvals from USFDA.

On Monday, the stock of the company closed at Rs. 521.75 per share, increase by 0.61 per cent or Rs. 3.15 per share. The 52-week high is Rs. 664 and 52-week low is Rs. 435.10 on BSE.