Zydus Lifesciences’ generic product has been approved by the US Food and Drug Administration

10. Zydus Lifesciences_ generic product has been approved by the US Food and Drug Administration

Zydus Lifesciences Ltd announced that it received final approval from the US health regulators to market its generic product of Cyanocobalamin injection.

The US Food and Drug Administration (USFDA) grant the permission. The approval 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, company explained. The production of drugs will be from the group’s injectable manufacturing facility at Jarod, Gujrat, said the company.

Cyanocobalamin injection is helpful in the treatment and prevention of vitamin B12 deficiency caused by pernicious anemia – a lack of natural substance required to absorb vitamin B12 from the intestine – such diseases reduce the amount of B12 absorbed from food.

According to Zydus Lifesciences, the company now has 331 approvals and has filed over 400 abbreviated new drug applications since the filing process began in FY 2003-04.

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