Shares of Alembic Pharmaceuticals Ltd rallied more than 12 per cent on Monday after the company received final approval from the US Food and Drug Administration (USFDA) for its generic Doxorubicin Hydrochloride Liposome Injection, a cancer treatment drug.

The stock climbed to an intraday high of Rs 1,086.7 on the NSE. Over the past month, Alembic Pharma share price has risen 7.86 per cent, driven by regulatory progress and investor optimism.

In a stock exchange filing on Sunday, Alembic Pharma announced that it received final USFDA approval for its abbreviated new drug application (ANDA) for Doxorubicin Hydrochloride Liposome Injection. The product will be available in 20 mg/10 ml (2 mg/ml) and 50 mg/25 ml (2 mg/ml) single-dose vials.

The approved drug is a therapeutic equivalent of Doxil Liposome Injection manufactured by Baxter Healthcare Corp. It is indicated for the treatment of ovarian cancer, AIDS-related Kaposi Sarcoma, and multiple myeloma.

According to IQVIA, the US market for Doxorubicin Hydrochloride Liposome Injection is estimated at $29 million for the 12 months ending March 2025. The approval marks a key step forward for Alembic’s US generics and oncology portfolio, where competition remains limited for complex injectable drugs.

In a separate development, Alembic Pharma confirmed that the USFDA issued an Establishment Inspection Report (EIR) for its API facility in Karakhadi, Gujarat. The inspection was conducted from March 17 to March 21, 2025, and concluded with a clean status, confirming the facility complies with US regulatory norms.

The EIR is an essential post-inspection document prepared by the USFDA, especially for facilities involved in manufacturing and exporting APIs to the US market.

The twin developments—USFDA product approval and facility clearance—have reinforced investor confidence in Alembic Pharmaceuticals’ growth in the US generics market, particularly in high-value oncology segments. Analysts believe that continued regulatory milestones could support further upside in the Alembic Pharma share price in the near to medium term.