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Aurobindo Pharma arm receives US FDA nod to manufacture, market Sevelamer Hydrochloride tablets - CNBCTV18

Shares of Aurobindo Pharma Ltd ended at Rs 732.45, down by Rs 3.65, or 0.50 percent on the BSE.

Pharmaceuticals manufacturer Aurobindo Pharma Ltd on Wednesday said its wholly-owned subsidiary has received approval from US Food and Drug Administration (US FDA) to manufacture and market Sevelamer Hydrochloride.

The drug maker said APL Healthcare Ltd has received final approval to manufacture and market Sevelamer Hydrochloride tablets 400 mg and 800 mg, Sevelamer Hydrochloride Tablets 400 mg and 800 mg, to be bioequivalent and therapeutically equivalent to the reference listed drug, Renagel tablets, 400 mg and 800 mg, of Genzyme Corporation.

Sevelamer Hydrochloride tablets 400 mg and 800 mg are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, Aurobindo Pharma said.

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