India'a largest pharmaceutical company Ranbaxy Laboratories Ltd has finally got nod from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) and Quinapril Hydrochloride & Hydrochlotothiazide (Quinapril + HCTZ) Tablets, an ACE inhibitor which is used to treat high blood pressure.
The company received approval for tablets in strength of 10mg/12.5mg, 20 mg/12.5mg and 20mg/225mg respectively.
An official release stated that, 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, Accuretic Tablets of Pfizer Pharmaceuticals Ltd.
It should be noted that this is the second ANDa approval granted by the USFDA, to Ranbaxy, in the last two months.
The application for the drug was submitted by Ranbaxy, from OHM Laboratories manufacturing facility, at New Jersey, USA.
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