Ranbaxy's cardio drug `Ramipril' gets US FDA approval
09 Mar 2009
Ranbaxy Laboratories Limited has received approval from the US Food and Drug Administration (USFDA) to manufacture and market its abbreviated new drug application (ANDA) Ramipril capsules 5mg and 10mg in the US.
The application drug was submitted by Ranbaxy from its Ohm Laboratories manufacturing facility in North Brunswick, New Jersey, US.
''The office of Generic Drugs, USFDA, 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 Inc,'' Ranbaxy said in a release.
`Altace' is registered trademark of King Pharmaceuticals inc.
''Ramipril is indicated in patients 55 years or older, who are at high risk of developing a major caridiovascular problem or diabetes that is accompanied by at least one other cardiovascular risk factor (hypertensive, elevated total cholesterol levels, low HDL levels, cigarette smoking or documented microalbuminuria) to reduce the risk of myocardial infarction, stroke or death from cardiovascular causes,'' the release said, adding the drug can be used in addition, to other needed treatment (such as anti-hypertensive, antiplatelet or lipid lowering therapy).
This is the third ANDA approval that Ohm Laboratories has received in the last two months, said Jim Meehan, vice president, sales and distribution, Ranbaxy in the US.
Ohm, based in North Brunswick, New Jersey, is a wholly owned subsidiary of Ranbaxy Laboratories Limited. Ohm is engaged in the sale and distribution of generic and branded private label, OTC products in the US healthcare system.
Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. Ranbaxy is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, has customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.
