The injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi Sarcoma and multiple myeloma.
The approved ANDA is for the 20mg/10 ml (2mg/ml) and 50 mg/25 ml (2mg/ml) strength single-dose vials. It is therapeutically equivalent to the reference-listed drug product of Doxil Liposome injection of the same strengths of Baxter Healthcare Corp.
As per IQVIA, the injection had an estimated market size of $29 million for 12 months till March 2025.
Last week, Alembic Pharma said the USFDA issued an establishment inspection report (EIR) for the company’s API facility in Karakhadi, Gujarat.
The USFDA had conducted this inspection between March 17, 2025, to March 21, 2025. The company announced the completion of the inspection on March 21, 2025.
An EIR here is a detailed document prepared by the USFDA after inspecting a facility that manufactures, processes, or distributes regulated pharmaceutical products.
Shares of Alembic Pharma gained over 12% to hit an intraday high of ₹1,086.7 apiece on Monday, June 30. The stock has gained 7.86% in the past month.
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