Aurobindo Pharma’s arm gets USFDA’s approval for Sevelamer Hydrochloride Tablets

12 Jul 2023 Evaluate

Aurobindo Pharma’s wholly owned subsidiary company -- APL Healthcare has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market 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 $37 million for the twelve months ending May 2023, according to IQVIA. This is the 57th 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.

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.


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