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.
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