Ranbaxy Laboratories Limited, has received an approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Quinapril hydrochloride & hydrochlorothiazide (Quinapril + HCTZ) tablets, 10mg/12.5mg, 20mg/12.5mg and 20mg/25mg.
The application for the drug was submitted by Ranbaxy, from its OHM Laboratories manufacturing facility, at New Jersey, USA. The Office of Generic Drugs, US FDA, had determined the Ranbaxy formulations to be bioequivalent and as having the same therapeutic effect as that of the reference listed drug, Accuretic tablets of Pfizer Pharmaceuticals Ltd.
This is the second ANDA approval granted by the US FDA, to Ranbaxy, within two month's period.
Quinapril + HCTZ, is an ACE inhibitor and is used to treat high blood pressure.
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 US healthcare system.