Zydus Lifesciences gets final USFDA approval for Cyanocobalamin Injection

18 Apr 2022 , 12:39 PM

Zydus Lifesciences Ltd (Formerly known as Cadila Healthcare Ltd.) has received final approval from the USFDA to market Cyanocobalamin Injection in the strengths of 1,000 mcg/mL,10,000 mcg/10 mL (1,000 mcg/mL), and 30,000 mcg/30 mL (1,000 mcg/mL) Multiple-Dose Vials. (US RLD: Cyanocobalamin).

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 decrease the amount of vitamin B12 absorbed from food.

Further, the drug will be manufactured at the group’s injectables manufacturing facility at Jarod, Gujarat.

The group now has 331 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04, said pharma major in a regulatory filing on Monday.

At around 12:41 PM, Zydus Lifesciences was trading at Rs359.65 apiece down by Rs5 or 1.37% on the BSE.