AstraZeneca Pharma India Limited has received permission to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 from Central Drugs Standard Control Organisation (CDSCO) for Budesonide Ph. Eur 160mcg+ Glycopyrronium Ph. Eur 7.2mcg+ Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations (BREZTRI AEROSPHERE).

Through this approval, BREZTRI AEROSPHERE is indicated for the maintenance treatment to relieve symptoms and prevent exacerbations in adult patients with chronic obstructive pulmonary disease (COPD).

The receipt of this permission paves way for the launch of Budesonide Ph. Eur 160mcg+ Glycopyrronium Ph. Eur 7.2mcg+ Formoterol Fumarate Dihydrate Ph. Eur 5mcg inhalation preparations (BREZTRI AEROSPHERE) in India for the above specified indication, subject to the receipt of related statutory approvals, if any.