USFDA23 Apr 2025, 04:50 pm
Aurobindo Pharma Subsidiary, Eugia Pharma, Receives USFDA Approval for Dasatinib Tablets
AI Summary
Aurobindo Pharma Limited announced that its wholly owned subsidiary, Eugia Pharma Specialities Limited, has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dasatinib Tablets. The product is expected to be launched in Q1FY26 and has an estimated market size of US$ 1.8 billion. This is the 181st ANDA approval for Eugia Pharma Specialities Group, manufacturing both oncology oral and sterile specialty products. Dasatinib Tablets are indicated for the treatment of certain types of leukemia and lymphoblastic leukemia.
Key Highlights
- Aurobindo Pharma's subsidiary, Eugia Pharma, receives USFDA approval for Dasatinib Tablets.
- The product is expected to be launched in Q1FY26 and has an estimated market size of US$ 1.8 billion.
- This is the 181st ANDA approval for Eugia Pharma Specialities Group.
- Dasatinib Tablets are indicated for the treatment of certain types of leukemia and lymphoblastic leukemia.
- Aurobindo Pharma has a robust product portfolio and a strong R&D setup.