Aurobindo Pharma-led arm bags USFDA Approval for Vasopressin Injection USP; stock under pressure

16 Aug 2022 , 10:59 AM

Aurobindo Pharma Limited announced that its wholly-owned subsidiary company, Eugia Pharma Specialties Limited, has secured the final approval from the US Food & Drug Administration (USFDA) for manufacturing and marketing Vasopressin Injection USP, 20 Units/mL Multiple-Dose Vials.

The company stated that Vasopressin Injection USP, 20 Units/mL Multiple-Dose Vials, are to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vasostrict Injection, 20 units/mL of Par Sterile Products, LLC (Par).

The company is planning to launch the product immediately.

As per the IQVIA data, the product has an estimated market size of around US$ 606 million for the twelve months ended June 2022.

This is the 146 ANDA (including ten tentative approvals) received by Eugia Pharma Speciality Group (EPSG) facilities, which manufacture both oral and sterile specialty products.

Vasopressin USP Injection is prescribed to treat Cardiovascular agent: vasoconstrictor. It is indicated to raise blood pressure in adults suffering from vasodilatory shock (for example, post-cardiotomy or sepsis).

At around 11.03 AM, Aurobindo Pharma was trading at Rs590.70 down by Rs2.6 or 0.44% from its previous closing of Rs593.30 on the BSE. The scrip opened at Rs594 and touched intraday high and low of Rs602.75 and Rs589.30 respectively.