Shares of Aurobindo Pharma Ltd rose over 2% after the company’s subsidiary, Eugia Pharma Specialities Ltd, received final approval from the U.S. Food & Drug Administration (USFDA) for Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampule. The drug is indicated for the maintenance treatment of asthma and as prophylactic therapy in children aged 12 months to 8 years. It is bioequivalent and therapeutically equivalent to the reference listed drug PULMICORT RESPULES (budesonide) Inhalation Suspension by Astrazeneca Pharmaceuticals LP. The company anticipates launching the product in the next fiscal year (FY25), and according to IQVIA data, the estimated market size for the product is $226.4 million for the 12 months ending September 2023. This marks the 173rd ANDA approval, including nine tentative approvals, for Eugia Pharma Specialities Group facilities.
Additionally, Aurobindo Pharma announced that it received USFDA final approval for Darunavir Tablet, indicated for the treatment of HIV in adults. The approval covers Darunavir Tablets in 600mg and 800mg strength, which are bioequivalent to the reference listed drug Prezista Tablets, 600mg and 800mg, of Janssen Products, LP. The product is scheduled to be launched on November 29, 2023. Aurobindo Pharma’s stock was trading 2.05% higher at ₹1,042.40 apiece at 1 pm.
These regulatory approvals highlight Aurobindo Pharma’s commitment to expanding its product portfolio and strengthening its presence in the pharmaceutical market. The company’s focus on gaining approvals for a diverse range of drugs, including those for critical therapeutic areas, positions it strategically in the pharmaceutical industry. The anticipated launch of Budesonide Inhalation Suspension and Darunavir Tablets will contribute to the company’s revenue growth and further establish its footprint in the global pharmaceutical market.
Aurobindo Pharma’s success in securing regulatory approvals underscores its research and development capabilities, adherence to quality standards, and ability to navigate the complex regulatory landscape. As the pharmaceutical industry continues to evolve, Aurobindo Pharma’s proactive approach to obtaining approvals for innovative and essential drugs positions it as a key player in meeting global healthcare needs.
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