Drug firm AstraZeneca Pharma India Ltd on Monday (November 18) said it has received import and market permission from the Drugs Controller General of India (DCGI) for its inhalation preparation, Breztri Aerosphere, combining budesonide (160mcg), glycopyrronium (7.2mcg), and formoterol fumarate dihydrate (5mcg).
“We refer to our earlier communication dated December 2, 2023, intimating the receipt of Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Budesonide Ph. Eur 160mcg+ Glycopyrronium Ph. Eur 7.2mcg+ Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations (Breztri Aerosphere),” the company said in a stock exchange filing.
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The combination medication is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) to relieve symptoms and prevent exacerbations in adult patients.
“With regard to the same, we wish to further update that AstraZeneca Pharma India Limited will launch Breztri Aerosphere in January 2025 in India,” AstraZeneca Pharma India said.
The company plans to launch Breztri Aerosphere in India in January 2025, marking a significant step forward in the treatment options available for COPD patients in the country.
Shares of AstraZeneca Pharma India Ltd ended at ₹6,398, down by ₹372.60, or 5.50%, on the BSE.
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(Edited by : Shoma Bhattacharjee)
