Alembic Pharma stock rallies 5% after firm receives USFDA tentative approval for Bosutinib tablets

In the last 12 months, the stock has soared 46 percent, beating Nifty's returns of 25 percent during this period.

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26 Aug, 2025 12:21

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Shares of Alembic Pharmaceuticals gained around five percent on July 1 after the company announced that has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bosutinib Tablets, 100 mg and 500 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Bosulif Tablets, 100 mg and 500 mg, of PF Prism C.V. (PF Prism).

Bosutinib tablets are indicated for the treatment of a certain type of leukaemia called Philadelphia chromosome-positive chronic myelogenous leukaemia, the company said.

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In a regulatory filing, Alembic Pharma stated that Bosutinib Tablets have an estimated market size of $275 million for twelve months ending March 2024, according to IQVIA.

Alembic is a vertically integrated research and development pharmaceutical company, which manufactures and markets generic pharmaceutical products all over the world.

It is one of the leaders in branded generics in India and has a cumulative total of 206 ANDA approvals (179 final approvals and 27 tentative approvals) from USFDA.

At 2:32 pm, Alembic Pharma shares were trading 4.7 percent higher at Rs 917.90 on the National Stock Exchange (NSE). So far this year, the stock has rallied 19.7 percent compared to a 10 percent rise in benchmark Nifty 50 index.

In the last 12 months, the stock has soared 46 percent, beating Nifty's returns of 25 percent during this period.

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