Third ANDA from Ranbaxy to be approved in the last two months.
Ranbaxy Laboratories Limited (Ranbaxy), announced today, that the Company has received an approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), to market and manufacture Ramipril Capsules 5mg & 10mg. The application for the drug was submitted by Ranbaxy from the Ohm Laboratories manufacturing facility, located in North Brunswick, New Jersey, USA. 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.
Ramipril is indicated in patients 55 years or older, who are at high risk of developing a major caridiovascular event 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. Ramipril can be used in addition, to other needed treatment (such as anti-hypertensive, antiplatelet or lipid lowering therapy).
"Ranbaxy is pleased to receive this final approval for Ramipril capsules. This is the third ANDA approval that materialized specific to Ohm Laboratories, in the last two months," said Jim Meehan, Vice President, Sales & Distribution, RPI, USA.
Ohm, based in North Brunswick, New Jersey, USA, 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 U.S. 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. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.
Ranbaxy Laboratories Limited, India's largest pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy’s continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company’s foray into Novel Drug Delivery Systems has led to proprietary "platform technologies," resulting in a number of products under development. The Company is serving its 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.
