Alembic Pharma shares rally 12% on USFDA nod for cancer drug
Alembic Pharmaceuticals
climbed as much as 12% on Monday to Rs 1,089.80 on BSE after the company received final approval from the US Food and Drug Administration (USFDA) for its generic version of
Doxorubicin Hydrochloride Liposome Injection
, a
cancer treatment
drug.
In a press release issued Sunday, the company announced that it had received final
USFDA approval
for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials.
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The company noted,
'The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.'
The injection is indicated for the treatment of ovarian cancer, AIDS-related Kaposi's sarcoma, and multiple myeloma.
'Refer to label for detailed indication,'
the company said.
Citing IQVIA data, Alembic estimated the market size of Doxorubicin Hydrochloride Liposome Injection in the U.S. to be $29 million for the twelve months ending March 2025.
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Growing US pipeline
Alembic's cumulative count of USFDA approvals now stands at 224 ANDAs, comprising 201 final approvals and 23 tentative approvals.
Earlier this month, on June 18, the company also received an Establishment Inspection Report (EIR) from the USFDA for its API-III facility in Karakhadi, following an inspection conducted from March 17 to March 21, 2025.
Stock performance and technicals
Alembic's stock has been on a steady uptrend. It has gained 22.7% in the past year, 2.5% in the past six months, 15.7% over the last three months, and 6.8% in the past month.
From a technical standpoint, the stock is currently trading above all its key simple moving averages (5-day to 200-day), signaling bullish momentum across time frames. The Relative Strength Index (RSI) is at 52.4, indicating neutral territory, while the Moving Average Convergence Divergence (MACD) is at 2.4, staying above its center line though still below its signal line.
The stock hit a 52-week high of Rs 1,296.15 on October 9, 2024, and a 52-week low of Rs 725.60 on March 3, 2025.
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