Aurobindo Pharma surges 8% on USFDA nod for Sevelamer Carbonate tablets

In past one month, the stock has outperformed the market by surging 21% against 1.64% gain in Sensex

Aurobindo Pharma surged 8% to Rs 795 on BSE in intra-day trade after the company announced that it has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets, a kidney disease drug.

“The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800mg,” Aurobindo Pharma said in a press release.

Sevelamer Carbonate tablets, a therapeutic equivalent generic version of Genzyme’s Renvela tablets. The product will be launched immediately, it added.

Sevelamer Carbonate tablets is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.

According to IMS, the approved product has an estimated market size of USD 1.9 billion for the 12-months ending May 2017.

This is the 124th Abbreviated New Drug Application or 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.

At 09:43 am; the stock was trading 5.5% higher at Rs 774 on BSE, as compared to 0.42% rise in the S&P BSE Sensex. A combined 6.37 million shares changed hands on the counter on BSE and NSE so far.

In past one month, the stock has outperformed the market by surging 21% against 1.64% gain in the benchmark index.