/ Aurobindo Pharma Receives USFDA Nod For Sevelamer Carbonate Tablets ~ Ways2Capital|Stock Tips|Stock Market Tips|Intraday Stock Tips|Stock Trading Tips|NSE BSE Tips

Wednesday, 19 July 2017

Aurobindo Pharma Limited on Wednesday announced that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate Tablets, 800mg. Sevelamer Carbonate tablets, a therapeutic equivalent generic version of Genzyme’s Renvela tablets. The product will be launched immediately.  

Sevelamer Carbonate tablets is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The approved product has an estimated market size of USD 1.9 billion for the 12-months ending May 2017, according to IMS. 

This is the 124th ANDA (including 21 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products for the company. 

Aurobindo now has a total of 331 ANDA approvals (294 Final approvals including 16 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.  

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