 "Aurobindo Pharma gains on USFDA nod for Sevelamer Carbonate oral suspension")
Aurobindo Pharma rallied 6% to Rs 639 on the BSE after the company said it has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate oral suspension, 0.8 gm and 2.4 gm.
Sevelamer Carbonate oral suspension, a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension. The product is being launched immediately, Aurobindo Pharma said in a statement.
Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, it added.
According to IMS, the approved product has an estimated market size of US$ 140 million for the twelve months ending April 2017.
This is the 116th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad used for manufacturing oral products.
Aurobindo now has a total of 323 ANDA approvals (288 Final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.
Sevelamer Carbonate oral suspension, a therapeutic equivalent generic version of Genzyme’s Renvela oral suspension. The product is being launched immediately, Aurobindo Pharma said in a statement.
Sevelamer Carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis, it added.
According to IMS, the approved product has an estimated market size of US$ 140 million for the twelve months ending April 2017.
This is the 116th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad used for manufacturing oral products.
Aurobindo now has a total of 323 ANDA approvals (288 Final approvals including 16 from Aurolife Pharma LLC and 35 tentative approvals) from USFDA.
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