Shares of Alembic Pharmaceuticals soared more than 12 percent in intra-day trade on Monday, June 30, after the company announced that it had secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Doxorubicin Hydrochloride Liposome Injection. The drug is used in the treatment of ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma. The development marks yet another milestone in the company’s growing US generics portfolio and sent investor sentiment soaring.
USFDA Approval
Alembic Pharmaceuticals, in its official press release, said it received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection in two dosage forms—20 mg/10 mL and 50 mg/25 mL single-dose vials. The approved product is a therapeutic equivalent to Baxter Healthcare Corporation’s Doxil Liposome Injection. The total market size for the drug in the US is estimated at USD 29 million for the twelve months ending March 2025, according to IQVIA.
The approval strengthens Alembic’s US generics pipeline, bringing its total number of ANDA approvals to 224, including 201 final and 23 tentative approvals. This comes close on the heels of another recent approval—earlier in June, Alembic had also received final USFDA clearance for its amlodipine and atorvastatin tablets, prescribed for hypertension management.
The consistent momentum in product launches, especially in complex generics, underscores the company’s focus on expanding its presence in the US market. This strategy has been a key earnings driver and is likely to support Alembic’s revenue visibility in the coming quarters.
Financials and Dividend
In addition to regulatory milestones, Alembic Pharma also announced a dividend for the financial year ending March 31, 2025. The record date to determine eligible shareholders has been set for Tuesday, July 29, 2025. The dividend will be distributed post the Annual General Meeting scheduled for August 5 and will be paid on or after August 7.
The company has a track record of consistent dividend payouts, having announced 14 dividends since July 2012. In the past year alone, it declared a total equity dividend of ₹11 per share.
Alembic’s financial performance also lent support to the stock’s rally. The company reported a 14 percent year-on-year rise in consolidated net profit at ₹24 crore in Q4 FY25, compared to ₹21 crore in the same quarter last year. Operational revenue grew to ₹60 crore from ₹49 crore a year earlier. For the full FY25, net profit rose to ₹145 crore, a 56 percent increase from ₹93 crore reported in FY24.
Stock Price Trend
The pharma stock jumped as much as 12.13 percent to its day’s high of ₹1089.80. It is now just 16 percent away from its 52-week high of ₹1,296.15, hit in October 2024. Meanwhile, it touched its 52-week low of ₹725.60 in March 2025.
In the last 1 year, the stock has added over 10 percent. Moreover, it advanced 6 percent in June after an over 16 percent rise in May. In April, it fell 5.8 percent after a 25 percent rally in March. Before that, it was in the red in 5 straight months between October 2024-Feb 2025.
