Alembic Pharma shares gain 10% on USFDA approval for Doxorubicin Hydrochloride Injection

Alembic Pharmaceuticals share price rose more than 10 percent intraday on June 30 after the company received USFDA approval for Doxorubicin Hydrochloride Injection.

At 13:22 hrs, Alembic Pharmaceuticals was quoting at Rs 1,073.90, up Rs 102.05, or 10.50 percent, on the BSE.

".... has received final approval from the US Food & Drug Administration (USFDA) 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," company said in its exchange filing.

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, it added.

The injection is indicated for the treatment of Ovarian Cancer, AIDS-Related Kaposi’s Sarcoma, and Multiple Myeloma. Refer label for a detailed indication.

The company has a cumulative total of 224 ANDA approvals (201 final approvals and 23 tentative approvals) from USFDA.

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On June 18, the company received an Establishment Inspection Report (EIR) from the USFDA after inspection carried out at API-III Facility at Karakhadi from March 17, 2025 to March 21, 2025.

The share touched a 52-week high of Rs 1,296.15 and a 52-week low of Rs 725.60 on 09 October, 2024 and 03 March, 2025, respectively.

Currently, the stock is trading 17.15 percent below its 52-week high and 48 percent above its 52-week low.The market capitalisation of the company stands at Rs 21,108.91 crore.