The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, US.
The office of generic drugs, FDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Altace by King Pharmaceuticals.
Jim Meehan, vice president of sales and distribution at Ranbaxy Pharmaceuticals USA, said: “Ranbaxy is pleased to receive this final approval for ramipril capsules. This is the third abbreviated new drug application approval that materialized specific to Ohm Laboratories, in the last two months.”