Biocon rises after subsidiary gets approval for multiple ANDAs from US FDA

Biocon rose 1.08% to Rs 318.20 after the company said that Biocon Pharmahas received final approvals from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug applications (ANDAs) for Lenalidomide Capsules and Dasatinib Tablets.

Lenalidomide is a medication used to treat types of multiple myeloma, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, and anemia in myelodysplastic syndromes (MDS) in adults.

Dasatinib is used to treat Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adults and children of 1 year of age and older. It is also used to treat Ph+CML and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) in adults after other medicines (eg, imatinib) or treatments did not work well. Dasatinib is also used in combination with chemotherapy to treat newly diagnosed Ph+ALL in children 1 year of age and older.

 

Additionally, Biocon Pharma has received tentative approval for its ANDA for Rivaroxaban Tablets USP, which is used to prevent blood clots and reduce the risk of stroke.

"These approvals further add to Biocons portfolio of vertically integrated, complex drug products," the company said in a statement.

Biocon is an innovation-led global biopharmaceuticals company engaged in the production of therapies for chronic conditions like diabetes, cancer, and autoimmune diseases. It has developed and commercialized novel biologics, biosimilars, and complex small-molecule APIs in India and several key global markets, as well as generic formulations in the US, Europe, & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company had reported a consolidated net profit of Rs 25 crore in Q3 FY25, which is significantly lower as compared with the PAT of Rs 660 crore posted in Q3 FY24. Revenue from operations fell by 3% YoY to Rs 3,821 crore during the period under review.

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