Drug firm AstraZeneca Pharma India Ltd on Thursday (March 6) said it has received approval from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import sodium zirconium cyclosilicate powder for oral suspension (Lokelma) in 5 g and 10 g formulations.
“This is to inform that AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India to import pharmaceutical formulations of new drug for sale or for distribution in Form CT-20 for Sodium Zirconium Cyclosilicate powder for oral suspension 5 g and 10 g (Lokelma),” AstraZeneca Pharma said in a regulatory filing.
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The approval granted in Form CT-20 allows AstraZeneca to import the drug for sale and distribution in India. Lokelma is indicated for the treatment of hyperkalaemia in adult patients, expanding treatment options for managing high potassium levels.
The receipt of this permission paves the way for the launch of sodium zirconium cyclosilicate powder for oral suspension 5 g and 10 g (Lokelma) in India, subject to the receipt of related statutory approvals, if any.
Shares of Astrazeneca Pharma India Ltd ended at ₹7,458.95, up by ₹117.65, or 1.60%, on the BSE.
