AstraZeneca Pharma India is eyeing to launch Dapagliflozin + Metformin Hydrochloride film coated tablets (XIGDUO XR) in India in Q4 of FY 2017-18. XIGDUO XR is a product of AstraZeneca Group and has been approved in 61 countries to date including US, EU and Japan.
Earlier in October, the company had received Import and Market Permission in Form 45 (Marketing Authorization) from the Drug Controller General of India (DCGI) for FDC of Dapagliflozin + Metformin Hydrochloride (Extended Release) film coated tablets.
XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.
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.