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Aurobindo Pharma receives US FDA approval for sevelamer oral suspension

Product is indicated to control serum phosphorus in patients with chronic kidney disease on dialysis

BS B2B Bureau  |  Hyderabad 

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Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture carbonate oral suspension (0.8 gm and 2.4 gm), which is a therapeutic equivalent generic version of Genzyme’s oral suspension. The company plans to launch the product very soon. 

carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on The approved product has an estimated market size of $ 140 million for the twelve months ending April 2017, according to IMS.

This is Aurobindo’s 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 US  

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Aurobindo Pharma receives US FDA approval for sevelamer oral suspension

Product is indicated to control serum phosphorus in patients with chronic kidney disease on dialysis

Product is indicated to control serum phosphorus in patients with chronic kidney disease on dialysis
Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture carbonate oral suspension (0.8 gm and 2.4 gm), which is a therapeutic equivalent generic version of Genzyme’s oral suspension. The company plans to launch the product very soon. 

carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on The approved product has an estimated market size of $ 140 million for the twelve months ending April 2017, according to IMS.

This is Aurobindo’s 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 US  

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Business Standard
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Aurobindo Pharma receives US FDA approval for sevelamer oral suspension

Product is indicated to control serum phosphorus in patients with chronic kidney disease on dialysis

Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture carbonate oral suspension (0.8 gm and 2.4 gm), which is a therapeutic equivalent generic version of Genzyme’s oral suspension. The company plans to launch the product very soon. 

carbonate oral suspension is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on The approved product has an estimated market size of $ 140 million for the twelve months ending April 2017, according to IMS.

This is Aurobindo’s 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 US  

image
Business Standard
177 22