Ajanta Pharma Limited, a specialty pharmaceutical formulation company, has received US FDA final approval for duloxetine hydrochloride delayed release capsules. It is a bioequivalent generic version of Cymbalta 1 delayed release capsules. The company will be launching the product shortly in 3 strengths, 20 mg, 30 mg and 60 mg strengths capsules.
Duloxetine hydrochloride delayed release capsules 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.