Ranbaxy gets US nod to manufacture generic amoxil

Thursday, 05 December 2002, 20:30 IST
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Indian pharmaceutical major Ranbaxy Laboratories Limited (RLL) has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Amoxicillin oral suspension through its subsidiary Ranbaxy Pharmaceuticals Inc. (RPI).

NEW DELHI: With this, Ranbaxy will be able to market generic Amoxicillin in liquid form of 200 mg per 5 ml and 400mg/5 ml in the US "Based on bio-equivalent studies, the formulation has been deemed to be bio-equivalent and therapeutically equivalent to amoxil for oral suspension 200 mg/5 ml and 400 mg/5 ml manufactured by GlaxoSmithKline," Ranbaxy said in a statement here Wednesday. Amoxicillin is prescribed for the treatment of infections of the ear, nose and throat, the genitourinary tract, the lower respiratory tract and gonorrhoea. Ranked second in antibiotic sales in the U.S. market, the total Amoxicillin market is estimated at $235.4 million. Suspensions account for $104.1 million and Amoxicillin in the 200 and 400 mg strengths totalling $ 63.4 million. The approval received by Ranbaxy is the first for any generic company to market this dosage form in the U.S. RPI has already received approvals for other forms of Amoxicillin: Amoxicillin 500mg and 875mg tablets, 250 mg and 500 mg capsules, 125 mg and 250 mg chewable tablets. "With this new approval, RPI is uniquely positioned to offer multiple dosage forms of Amoxicillin that include capsules, tablets, chewable tablets and suspensions in multiple strengths and package sizes," Ranbaxy stated.
Source: IANS