Zydus Lifesciences Gets Approval From USFDA For Vit B12 Injection

Zydus Lifesciences' injectable manufacturing facility in Jarod, Gujarat, will produce the injection vials.

Zydus Lifesciences Limited, Pharma major on Monday announced in its regulatory filing that the US Food and Drug Administration (USFDA) has given final approval to market Cyanocobalamin Injection. The company has been approved to market the Vitamin B12 vaccine in multiple-dose vials of 1,000 mcg/mL, 10,000 mcg/10 mL (1,000 mcg/mL), and 30,000 mcg/30 mL (1,000 mcg/mL).

“Cyanocobalamin injection is used to treat and prevent lack of vitamin B12 that may be caused due to pernicious anaemia (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,” said the company in a statement.

Zydus Lifesciences’ injectable manufacturing facility in Jarod, Gujarat, will produce the injection vials.

The group now has 331 approvals and has filed so far and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus’ global business has a strong presence in regulated markets such as the United States, Europe (France and Spain), and high-profile markets such as Latin America and South Africa. It is also prevalent in 25 other emerging markets around the world.

Zydus Group is headquartered in Ahmedabad, India, and is the fourth-largest pharmaceutical company in the country. The group has manufacturing and research facilities in five Indian states: Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim, as well as the United States and Brazil.

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