Zydus Lifesciences bags USFDA nod for Vitamin B12 injection Cyanocobalamin
The drug will be manufactured at the group's injectables manufacturing facility at Jarod, Gujarat.
Ahmedabad: Zydus Lifesciences Ltd. (Formerly known as Cadila Healthcare Ltd.) today announced that the company has received final approval from the U. S. Food and Drug Administration (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.
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.
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Zydus group is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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