AstraZeneca Pharma India 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.
AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.
