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Aurobindo Pharma Shares Gain on Receiving USFDA Approval for Asthma Drug

The EIR relates to Aurobindo Pharma's new injectable manufacturing facility in Parawada Mandal.

Shares of Aurobindo Pharma were trading in the green and 2% higher on 30 November after the company’s wholly-owned subsidiary received final approval from the USFDA (US Food and Drug Administration) to manufacture and market asthma drug.

The company’s wholly-owned subsidiary, Eugia Pharma Specialities Limited, has received approval to manufacture and sell Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule.

The drug is a therapeutic and bioequivalent to the reference listed drug, Pulmicort Respules (budesonide) inhalation suspension of AstraZeneca Pharmaceuticals.

The product is expected to be launched in FY25 and has an estimated market size of $226.4 million in a year, according to IQVIA.

This is the company’s 173rd ANAD (abbreviated new drug application) approval, including the nine tentative approvals received by Eugia Pharma Specialities Group, which manufactures both oral and sterile speciality products.

On 29 November, the company received approval from the USFDA to market a generic medication that treats human immunodeficiency virus (HIV-1) infection. It had received final approval to manufacture and market Darunavir tablets in strengths of 600 mg and 800 mg.

At 3:30 pm, the shares of Aurobindo Pharma closed 2.31% higher at Rs 1,045 on NSE.

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