Drug Approval | July 24, 2024
Zydus receives USFDA’s final approval for Valsartan Tablets
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death
Sacu V is priced at Rs. 19 per tablet for a dose of 50 mg (sacubitril 24 mg + valsartan 26 mg)
Dr. Reddy's valsartan tablets, USP are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90
Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.
ICICI Direct analysis of Dr Reddy’s Q3FY22 results
The company will engage with the agency to resolve the import alert at the earliest and ensure cGMP compliance.
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