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Zydus Lifesciences gets USFDA nod for generic product

The approval granted by the US Food and Drug Administration (USFDA) is for Cyanocobalamin injection in strengths of 1,000 mcg/ml, 10,000 mcg/10 ml and 30,000 mcg/30 ml multiple-dose vials, the company said in a regulatory filing.

Zydus Lifesciences gets USFDA nod for generic product
Zydus Lifesciences said the group now has 331 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Ltd on Monday said it has received final approval from the US health regulator to market its generic version of Cyanocobalamin injection which is used to treat and prevent vitamin B12 deficiency caused by pernicious anemia.

The approval granted by the US Food and Drug Administration (USFDA) is for Cyanocobalamin injection in strengths of 1,000 mcg/ml, 10,000 mcg/10 ml and 30,000 mcg/30 ml multiple-dose vials, the company said in a regulatory filing.

“The drug will be manufactured at the group’s injectables manufacturing facility at Jarod, Gujarat,” it added.The company said Cyanocobalamin injection is used to treat and prevent lack of vitamin B12 that may be caused due to pernicious anemia — lack of a natural substance needed to absorb vitamin B12 from the intestine — , certain diseases, infections or medications that decrease the amount of vitamin B12 absorbed from food.

Zydus Lifesciences said the group now has 331 approvals and has so far filed over 400 abbreviated new drug applications since the commencement of the filing process in FY 2003-04.

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First published on: 18-04-2022 at 03:29:51 pm