Shares of Alembic Prescribed drugs Ltd rallied greater than 12 per cent on Monday after the corporate obtained closing approval from the US Meals and Drug Administration (USFDA) for its generic Doxorubicin Hydrochloride Liposome Injection, a most cancers therapy drug.
The inventory climbed to an intraday excessive of Rs 1,086.7 on the NSE. Over the previous month, Alembic Pharma share value has risen 7.86 per cent, pushed by regulatory progress and investor optimism.
Alembic Prescribed drugs Will get USFDA Approval for Doxorubicin Hydrochloride Liposome Injection
In a inventory trade submitting on Sunday, Alembic Pharma introduced that it obtained closing USFDA approval for its abbreviated new drug software (ANDA) for Doxorubicin Hydrochloride Liposome Injection. The product will probably be obtainable in 20 mg/10 ml (2 mg/ml) and 50 mg/25 ml (2 mg/ml) single-dose vials.
The accredited drug is a therapeutic equal of Doxil Liposome Injection manufactured by Baxter Healthcare Corp. It’s indicated for the therapy of ovarian most cancers, AIDS-related Kaposi Sarcoma, and a number of myeloma.
Alembic Pharma Eyes $29 Million US Market with Oncology Drug Launch
In keeping with IQVIA, the US marketplace for Doxorubicin Hydrochloride Liposome Injection is estimated at $29 million for the 12 months ending March 2025. The approval marks a key step ahead for Alembic’s US generics and oncology portfolio, the place competitors stays restricted for advanced injectable medicine.
Alembic Prescribed drugs Receives USFDA EIR for Karakhadi API Facility
In a separate growth, Alembic Pharma confirmed that the USFDA issued an Institution Inspection Report (EIR) for its API facility in Karakhadi, Gujarat. The inspection was performed from March 17 to March 21, 2025, and concluded with a clear standing, confirming the ability complies with US regulatory norms.
The EIR is a vital post-inspection doc ready by the USFDA, particularly for services concerned in manufacturing and exporting APIs to the US market.
Optimistic Outlook for Alembic Pharma as Regulatory Wins Increase Confidence
The dual developments—USFDA product approval and facility clearance—have bolstered investor confidence in Alembic Prescribed drugs’ development within the US generics market, notably in high-value oncology segments. Analysts imagine that continued regulatory milestones may help additional upside within the Alembic Pharma share value within the close to to medium time period.
