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Alembic Pharma Shares Rose 2% on USFDA Nod

The USFDA carried out the inspection between 17 March and 21 March 2025.
The USFDA carried out the inspection between 17 March and 21 March 2025.

Shares of Alembic Pharma Ltd rose 2% on Friday, 30 May, after the company announced receiving final approval from the USFDA for its blood cancer drug, Bosutinib Tablets.

Earlier on Friday, 30 May, Vadodara-based Alembic Pharmaceuticals Ltd. announced that the U.S. Food and Drug Administration (USFDA) had granted final approval for its Bosutinib Tablets in 100 mg and 500 mg strengths, used to treat Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in chronic, accelerated, or blast phases with resistance.

Moreover, Alembic highlighted in an exchange filing that the approved drug targets a market estimated at $291 million for the twelve months ending March 2025. 

Additionally, with this approval, the company has secured a cumulative total of 223 Abbreviated New Drug Application (ANDA) approvals from the USFDA, including 200 final and 23 tentative.

Pfizer markets the same drug under the brand name Bosulif.

Earlier, in April 2025, Alembic also received USFDA approval for carbamazepine tablets, a treatment for neurological disorders.

At 3:30 pm, the shares of Alembic Pharma closed 1.23% higher at Rs 1,018.90 on NSE.

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