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
• Indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
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Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 155 countries.
The company has 27 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA.
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