 "Ajanta Pharma facility")
Ajanta Pharma Ltd has received from the US Food and Drug Administration's (FDA) final approval for almotriptan malate tablets (6.25 mg & 12.5 mg), a generic version of Janssen Pharmaceuticals' Axert, for the treatment of acute migraine pain relief. The company will be launching the product in US shortly.
Currently, Ajanta Pharma has four products available in the US market namely, risperidone tablets and three versions of montelukast sodium in regular tablets, chewable tablets & oral granules.
Almotriptan tablet is a part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. This approval will further strengthen its presence in the US - the world's largest pharma market.
In total, the company has 26 ANDAs out of which, it has final approvals for 8 ANDAs, tentative approvals for 2 ANDAs and 16 ANDAs are under review with FDA.
