Aurobindo Pharma arm gets USFDA nod for Budesonide Inhalation Suspension for asthma

Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule is indicated for maintenance treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years.;

Published On 2023-11-30 06:50 GMT | Update On 2023-11-30 12:24 GMT

Hyderabad: Aurobindo Pharma Limited has announced that its wholly-owned subsidiary company, 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, 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 US$ 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 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 of age 12 months to 8 years.

Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, and occurs in people of all ages. It is the most common chronic disease among children.

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. The company has 25 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. The company’s product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, AntiRetroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Aurobindo Pharma arm gets USFDA nod for Budesonide Inhalation Suspension for asthma

Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule is indicated for maintenance treatment of asthma and as prophylactic therapy in children of age 12 months to 8 years.;

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