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Alembic Pharmaceuticals Limited has received tentative approval from the US Food and Drug Administration (USFDA) for its Bosutinib Tablets, 400 mg, the company said on Monday, January 12.
In a regulatory filing, Alembic Pharma said the tentative approval has been granted for its supplemental Abbreviated New Drug Application (sANDA). The product is therapeutically equivalent to Bosulif Tablets, 400 mg, marketed by PF Prism C.V., it added.
Bosutinib is a kinase inhibitor used in the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), including newly-diagnosed patients as well as those who are resistant or intolerant to prior therapies. It is also indicated for adult patients with accelerated or blast phase Ph+ CML who have shown resistance or intolerance to earlier treatments.
Alembic noted that it has already received final USFDA approvals for Bosutinib Tablets in the 100 mg and 500 mg strengths. The 400 mg dosage represents an additional opportunity in the molecule’s lifecycle.
According to IQVIA data cited by the company, Bosutinib Tablets, 400 mg, had an estimated market size of $251 million in the US for the twelve months ended September 2025.
With this approval, Alembic Pharma’s cumulative ANDA approvals from the USFDA stand at 232, comprising 212 final approvals and 20 tentative approvals, underlining its continued focus on the US generics market.
Alembic Pharmaceuticals is a vertically integrated pharmaceutical company with operations spanning research, development, manufacturing and marketing of generic medicines across key global markets.
The pharma major received final approval from the USFDA for its ANDA in November for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths.
The company reported a 21% year-on-year rise in consolidated net profit to ₹185 crore, from ₹153 crore a year earlier. Revenue grew 16% to ₹1,910 crore from ₹1,648 crore in the same period last year. EBITDA increased 32% year-on-year to ₹315.3 crore, while operating margins expanded to 16.5% from 14.5% a year ago.
Shares of the company were trading 0.53% down at ₹795.70 as of 12.25 pm. The stock has dropped 9.26% in the last one month.
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In a regulatory filing, Alembic Pharma said the tentative approval has been granted for its supplemental Abbreviated New Drug Application (sANDA). The product is therapeutically equivalent to Bosulif Tablets, 400 mg, marketed by PF Prism C.V., it added.
Bosutinib is a kinase inhibitor used in the treatment of adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), including newly-diagnosed patients as well as those who are resistant or intolerant to prior therapies. It is also indicated for adult patients with accelerated or blast phase Ph+ CML who have shown resistance or intolerance to earlier treatments.
Alembic noted that it has already received final USFDA approvals for Bosutinib Tablets in the 100 mg and 500 mg strengths. The 400 mg dosage represents an additional opportunity in the molecule’s lifecycle.
According to IQVIA data cited by the company, Bosutinib Tablets, 400 mg, had an estimated market size of $251 million in the US for the twelve months ended September 2025.
With this approval, Alembic Pharma’s cumulative ANDA approvals from the USFDA stand at 232, comprising 212 final approvals and 20 tentative approvals, underlining its continued focus on the US generics market.
Alembic Pharmaceuticals is a vertically integrated pharmaceutical company with operations spanning research, development, manufacturing and marketing of generic medicines across key global markets.
The pharma major received final approval from the USFDA for its ANDA in November for Diltiazem Hydrochloride Tablets USP in 30 mg, 60 mg, 90 mg, and 120 mg strengths.
The company reported a 21% year-on-year rise in consolidated net profit to ₹185 crore, from ₹153 crore a year earlier. Revenue grew 16% to ₹1,910 crore from ₹1,648 crore in the same period last year. EBITDA increased 32% year-on-year to ₹315.3 crore, while operating margins expanded to 16.5% from 14.5% a year ago.
Shares of the company were trading 0.53% down at ₹795.70 as of 12.25 pm. The stock has dropped 9.26% in the last one month.
Also Read: Maruti Suzuki India approves land parcel purchase worth nearly ₹5,000 crore in Gujarat; Stock falls
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