Shares of Alembic Pharmaceuticals Ltd ended flat after touching a day’s high of Rs 804.15 on 12th January, even as the company said it had received tentative approval from the US Food and Drug Administration (USFDA) for its Bosutinib Tablets, 400 mg.

In a regulatory filing, Alembic Pharma said it has received tentative approval from the USFDA for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400 mg. The drug is therapeutically equivalent to Bosulif Tablets, 400 mg. Bosulif Tablets are marketed by PF Prism C.V.

Bosutinib is used to treat adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukaemia (CML). This includes newly diagnosed patients and those who are resistant or intolerant to earlier treatments. It is also indicated for patients with advanced disease.

Alembic noted it already has final USFDA approvals for Bosutinib Tablets in 100 mg and 500 mg strengths. The 400 mg dosage adds another growth opportunity. As per company-cited IQVIA data, the 400 mg Bosutinib tablets had an estimated US market size of $251 million for the 12 months ended September 2025.

With this approval, Alembic Pharma’s total ANDA approvals from the USFDA stand at 232. This includes 212 final and 20 tentative approvals. This highlights its strong focus on the US generics market.

Separately, the company recently received final USFDA approval for Diltiazem Hydrochloride Tablets USP in multiple strengths. Alembic reported a 21% year-over-year rise in consolidated net profit to Rs 185 crore. Meanwhile, revenue grew 16% to Rs 1,910 crore. EBITDA rose 32%, with operating margins improving to 16.5%.

At 3:30 PM, shares of Alembic Pharmaceuticals ended 0.24% lower at Rs 798 on NSE.

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