Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Sevelamer Carbonate tablets 800mg.
Sevelamer Carbonate tablets, a therapeutic equivalent generic version of Genzyme’s Renvela® tablets. The product is being launched immediately.
Sevelamer Carbonate tablets is indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The approved product has an estimated market size of US$ 1.9 billion for the twelve months ending May 2017 according to IMS.
This is the 124th ANDA (including 21 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 331 ANDA approvals (294 Final approvals including 16 from Aurolife Pharma LLC and 37 tentative approvals) from USFDA.
About Aurobindo Pharma Limited:
Aurobindo Pharma Limited (www.aurobindo.com) , headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and AntiDiabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.
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