Aurobindo Pharma Limited announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Paricalcitol Capsules, 1 mcg, 2 mcg, and 4 mcg. This product is expected to be launched in First Quarter FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zemplar® capsules 1 mcg, 2 mcg and 4 mcg of ABBVIE.

Paricalcitol Capsules is used for the prevention and treatment of high levels of parathyroid hormone in certain patients with chronic kidney disease. The approved product has an estimated market size of $38 million for the twelve months ending November 2015 according to IMS. This is the 58th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 231 ANDA approvals (200 Final approvals including 10 from Aurolife Pharma LLC and 31 Tentative approvals) from USFDA.