USFDA nod to Aurobindo Pharma arm's Vasopressin Injection
Hyderabad: Drugmaker, Aurobindo Pharma Limited, today announced that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vasopressin Injection USP, 20 Units/mL Multiple-Dose Vials.
Vasopressin Injection USP, 20 Units/mL Multiple-Dose Vials, to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vasostrict Injection, 20 units/mL of Par Sterile Products, LLC (Par). The product is being launched Immediately.
The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA. This is the 146 th ANDA (including 10 tentative approvals received) out of Eugia Pharma Speciality Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
Vasopressin Injection USP is indicated for the treatment of Cardiovascular agent: vasoconstrictor
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