Zydus Lifesciences gets USFDA approval to market generic drug

Zydus Lifesciences said it has received approval from the US health regulator to market a generic medication to prevent and treat blood clots. The company has received approval from the US Food and Drug Administration (USFDA) to market Apixaban tablets in strengths of 2.5 and 5 mg, according to a regulatory filing. Apixaban blocks the activity of certain clotting substances in the blood. It is used to lower the risk of stroke or a blood clot in people with a heart rhythm disorder called atrial fibrillation. It is also used to reduce the risk of forming a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery.

The drug will be manufactured at the Zydus group's formulation manufacturing facility at Moraiya, Ahmedabad. As per IQVIA MAT December 2022 data, Apixaban tablets had annual sales of USD 18,876 million in the US. Zydus Lifesciences Limited (Formerly Cadila Healthcare Limited) is a leading Indian pharmaceutical company that is a fully integrated global healthcare provider. It has strong capabilities across the pharmaceutical value chain and has extensive domain expertise in healthcare.

Zydus has a reputation among Indian pharmaceutical companies for providing comprehensive and complete healthcare solutions, ranging from formulations to active pharmaceutical ingredients and animal healthcare products to wellness products. The rich history and lineage of Zydus is one of its most notable features. The company's origins can be traced back to the 1950s. Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and doyen in the field of Indian Pharmaceuticals, founded the company in 1952.