ASTRAZENECA PHARMA INDIA LTD. - 506820 - Astrazeneca Pharma India Limited Receives Import And Market Permission ...
BSE India
This is to inform that AstraZeneca Pharma India Limited has received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Dapagliflozin Tablets 10mg. Dapagliflozin Tablets 10mg is now approved for additional indication: For the treatment of patients of Chronic Kidney Disease up to Stage III (eGFR of greater than or equal to 30ml/min/1.73m2). The receipt of this permission paves way for the launch of Dapagliflozin Tablets 10mg into a new disease area to Nephrologists in India, subject to the receipt of related statutory approvals and licenses.