Aurobindo Pharma’s Eugia Pharma Receives USFDA Approval for Budesonide Inhalation Suspension (0.5 mg/2 mL Single-Dose Ampule)

Aurobindo Pharma Limited is delighted to announce that its wholly-owned subsidiary, Eugia Pharma Specialities Limited, 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. This product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), PULMICORT RESPULES® (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP. The product launch is expected in FY25. The approved product has an estimated market size of US$ 226.4 million for the twelve months ending September 2023, according to IQVIA.

About Aurobindo Pharma

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 150 countries.

This marks the 173rd ANDA approval (including 9 tentative approvals received) from Eugia Pharma Specialities Group (EPSG) facilities, which manufacture both oral and sterile specialty 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.

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