Alembic Pharmaceuticals Share Price Surges Nearly 14% After USFDA Approval for Generic Cancer Drug

Alembic Pharmaceuticals Ltd experienced a significant boost in its stock value, surging nearly 14% on Monday. This rise followed the company's announcement of receiving final approval from the United States Food and Drug Administration (USFDA) for its generic Doxorubicin Hydrochloride Liposome Injection, a drug used to treat cancer.

Alembic Pharmaceuticals Share Price Today

On June 30, shares of Alembic Pharmaceuticals Ltd witnessed a sharp rally, soaring by 13.59% to trade at Rs 1,100.60 as of 11:36 AM. The stock opened significantly higher at Rs 989.00, compared to the previous close and quickly gained momentum to touch an intraday high of Rs 1,107.90. The day's low was Rs 988.90, showing strong buying interest throughout the morning session.

The current price surge brings the stock closer to its 52-week high of Rs 1,303.90, although it still remains below that peak. Notably, Alembic Pharma's 52-week low stands at Rs 725.20, indicating a strong recovery and bullish sentiment over the recent months.

Over the past month, Alembic Pharma's share price has increased by 7.86%, driven by regulatory advancements and investor optimism.

In a recent filing with the stock exchange, Alembic Pharma revealed that it had secured final USFDA approval for its abbreviated new drug application (ANDA) for Doxorubicin Hydrochloride Liposome Injection. This product will be available in two single-dose vial options: 20 mg/10 ml (2 mg/ml) and 50 mg/25 ml (2 mg/ml). The approved medication is therapeutically equivalent to Doxil Liposome Injection produced by Baxter Healthcare Corp. It is intended for treating ovarian cancer, AIDS-related Kaposi Sarcoma, and multiple myeloma.

Alembic Pharma Targets $29 Million Market

The US market for Doxorubicin Hydrochloride Liposome Injection is projected to be worth $29 million for the year ending March 2025, according to IQVIA. This approval represents a significant advancement for Alembic's generics and oncology portfolio in the US, where competition remains limited for complex injectable drugs.

In another development, Alembic Pharma announced that the USFDA issued an Establishment Inspection Report (EIR) for its API facility located in Karakhadi, Gujarat. The inspection took place from March 17 to March 21, 2025, and concluded with a clean status, confirming that the facility adheres to US regulatory standards. The EIR is a crucial post-inspection document prepared by the USFDA, particularly for facilities involved in manufacturing and exporting APIs to the US market.

About Alembic Pharmaceuticals

Founded in 1907, Alembic Pharmaceuticals is one of India's oldest and most respected pharmaceutical firms. It is headquartered in Vadodara, Gujarat, and has built a legacy of over a century in the Indian pharmaceutical landscape. Alembic operates across the entire pharmaceutical value chain, with competencies in Active Pharmaceutical Ingredients (APIs), generic formulations, injectables, oncology, dermatology, ophthalmology, and other therapeutic categories.

The company has established a strong global footprint, with operations in over 90 countries. Its key markets include the United States, Canada, Europe, Brazil, Australia, and South Africa, making it a significant player in the international pharmaceutical export market.

Alembic Pharmaceuticals places a strong emphasis on innovation and R&D, allocating between 12% and 14% of its revenue toward research and development annually. The company operates R&D centers in Vadodara and Hyderabad in India, as well as in New Jersey, USA. These centers are backed by a team of over 1,200 scientists, focusing on developing complex generics and specialty drugs for highly regulated markets like the U.S.

As of now, Alembic has filed over 250 ANDAs (Abbreviated New Drug Applications), 132 DMFs (Drug Master Files), and has received approval for more than 110 ANDAs, reflecting the company's robust pipeline. Alembic runs five USFDA-approved facilities in India, which manufacture APIs, oral solid dosage forms, dermatological products, and sterile injectables-supporting the company's aggressive push into complex and high-margin therapeutic areas.