Aurobindo Pharma arm gets USFDA’s approval for Budesonide Inhalation Suspension

At 2 pm, Aurobindo Pharma shares were trading at Rs 1,038, up by 1.65% from its previous closing of Rs 1,021.15 on the BSE.

Receiving USFDA approval 

Aurobindo Pharma’s wholly owned subsidiary, Eugia Pharma Specialities has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), PULMICORT RESPULES (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP. The product is expected to be launched in FY25. The approved product has an estimated market size of USD 226.4 million for the twelve months ending September 2023, according to IQVIA.

This is the 173rd ANDA approval (including 9 tentative approvals received) out of Eugia Pharma Specialities Group (EPSG) facilities, manufacturing both oral and sterile speciality products. Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule is indicated for maintenance treatment of asthma and as prophylactic therapy in children aged 12 months to 8 years.

Company profile 

Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.

Stock price movement 

The scrip opened at Rs 1,030.55 and has touched a high and low of Rs 1,046 and Rs 1,023.55 respectively. The BSE group ‘A’ stock of face value of Rs 1 has a 52-week high and low of Rs 1058.95 and Rs 397.30, respectively. Last one week high and low of the scrip stood at Rs 1,046 and Rs 1,009.75 respectively. The current market cap of the company is Rs 60,820.43 crore.

The promoters holding in the company stood at 51.83%, while Institutions and Non-Institutions held 40.74% and 7.42% respectively.

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