AstraZeneca Pharma has announced that the company received Import and Market Permission in Form CT-20 (Subsequent New Drug Approval) from the Drugs Controller General of India for Dapagliflozin Tablets 10mg.
According to the regulatory filing, Dapagliflozin Tablets 10mg is now approved for additional indication such as for the treatment of patients of Chronic Kidney Disease up to Stage III (eGFR of greater than or equal to 30ml/min/1.73m).
AstraZeneca Pharma said, "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."
At around 3.16 pm, AstraZeneca Pharma was trading at Rs3881.50 per piece down by Rs13.60 or 0.35% on Sensex.
The stock has touched an intraday high and low of Rs3957.50 per piece and Rs3880.90 per piece in early trade.