Aurobindo Pharma arm bags USFDA nod for Sevelamer Hydrochloride Tablets
Sevelamer Hydrochloride Tablets 400 mg and 800 mg is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
Hyderabad: Aurobindo Pharma Limited has announced that it’s wholly owned subsidiary company, APL Healthcare Limited, has received a final approval from the US Food & Drug Administration (USFDA) 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 (RLD), Renagel Tablets, 400 mg and 800 mg, of Genzyme Corporation.
The approved product has an estimated market size of around US$ 37 million for the twelve months ending May 2023, according to IQVIA. This is the 57 th ANDA approved out of APL Healthcare Unit IV formulation facility, used for manufacturing oral products.
Aurobindo now has a total of 463 ANDA approvals (437 Final approvals and 26 tentative approvals) from USFDA.
Sevelamer Hydrochloride Tablets 400 mg and 800 mg is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
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