Astrazeneca Pharma receives DCGI approval for launch of diabetes drug in India

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Capital Market
Last Updated : Sep 26 2019 | 11:31 AM IST
Astrazeneca Pharma India has received Import and Market permission in Form 45 (Marketing Authorization) from the Drugs Controller General of India for FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets.

The receipt of this Import and Market permission paves way for the launch of FDC of Dapagliflozin 10mg + Saxagliptin 5mg film coated tablets (QTERN) in India, subject to the receipt of other related statutory approvals and licenses.

FDC of Dapagliflozin 10mg + Saxagliptin 5mg is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM).

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First Published: Sep 25 2019 | 8:11 PM IST

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