Aurobindo Pharma Limited is pleased to announce that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a 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 146th 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
Indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Commenting on the USFDA approval, Mr. Yugandhar Puvvala, CEO, Eugia Pharma Specialities Ltd. said, “Vasopressin Injection, is a limited competition complex product for Eugia portfolio and we expect to add significant revenue in FY23”