Shares of Alembic Pharmaceuticals Ltd skyrocketed more than 14% on 30 June after the company announced on Sunday that it had received final USFDA approval for its abbreviated new drug application (ANDA) for Doxorubicin Hydrochloride Liposome injection.
The injection is used to treat ovarian cancer, AIDS-associated Kaposi Sarcoma, and multiple myeloma.
The approved ANDA covers single-dose vials of 20mg/10 ml (2mg/ml) and 50mg/25 ml (2mg/ml) strength. It is therapeutically identical to the reference-listed medicinal product Doxil Liposome injection of the same strengths manufactured by Baxter Healthcare Corp.
According to IQVIA, the injection’s market size was expected to be $29 million for the 12-month period ending in March 2025.
Last week, Alembic Pharma announced that the USFDA had issued an establishment inspection report (EIR) for the company’s API facility in Karakhadi, Gujarat.
The USFDA conducted this inspection between 17 and 21 March 2025. The business claimed that the examination would be completed on 21 March 2025.
An EIR is a detailed document created by the US FDA after examining a facility that manufactures, processes, or distributes regulated pharmaceutical items.
At 1:31 pm, the shares of Alembic Pharma were trading 9.41% higher at 1,060.10 on NSE.
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