Ajanta Pharma receives US FDA nod for Duloxetine capsules

Mumbai headquartered specialty pharmaceutical company Ajanta Pharma in an exchange filing informed that it has received final approval for Duloxetine Hydrochloride delayed release capsules from the US FDA.

Duloxetine Hydrochloride delayed release capsule is a bioequivalent generic version of Cymbalta delayed release capsule. The company plans to launch the product shortly in three strengths.

Duloxetine Hydrochloride capsule is used for curing depression and generalised anxiety disorders. It manages pain caused due to fibromyalgia and diabetic peripheral neuropathy.

Duloxetine Hydrochloride capsule is part of an ever-growing portfolio of products that Ajanta has developed for the US market.

In total, Ajanta has 32 Abbreviated New Drug Application (ANDA) of which it has 17 final ANDA approvals, 2 tentative approvals and 13 ANDAs under review with US FDA.

Ajanta Pharma stock is likely to be in focus on January 10, 2017. However, the stock has not been performing well on the bourses in the past quarter or so and has delivered negative returns of close to 10 per cent, bogged down by all the negative news concerning the Indian pharma industry and other regulatory concerns.