Alembic Pharma Gets FDA Approval
In an exchange filing, the company said that the US Food & Drug Administration (USFDA) has granted it the ‘Final Approval’ for Bosutinib Tablets, 100 mg and 500 mg.
This drug is used for treating patients with chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance.
Bosutinib Tablets, 100 mg and 500 mg, have an estimated market size of $291 million for the twelve months ending March 2025.
The company also added that it has received a cumulative total of 223 Abbreviated New Drug Application (ANDA) approvals (200 final approvals and 23 tentative approvals) from the USFDA so far.
This drug is also marketed under the brand name Bosulif by American pharma giant Pfizer.
In April 2025, the company had also received the US FDA nod for carbamazepine tablets, used for neurological disorders.
Q4 ResultsÂ
In its fourth quarter results announced earlier this month, the drugmaker saw its profits fall. Its consolidated net profit fell 11.8% year-on-year to ₹157 crore, compared to ₹178 crore in the same quarter last year.
The company’s revenue rose 16.7% to ₹1,769.6 crore.
In addition, the EBITDA (Earnings Before Interest, Taxes, Depreciation, and Amortisation) margin narrowed to 15.4% from 17.1% a year earlier.
Shares of Alembic Pharma are trading 1.1% higher after the announcement at ₹1,018.15. The stock has gained 16% in the last one month and has nearly reversed its losses for the year. Shares are down 3% so far in 2025.
