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Alembic Pharmaceuticals Limited announced on Monday, January 12, that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Bosutinib Tablets, 400 mg. This marks another step forward in the company's strategic expansion within the crucial U.S. generics market.
USFDA Green Light for Bosutinib
The tentative approval pertains to Alembic Pharma's supplemental Abbreviated New Drug Application (sANDA). The 400 mg dosage is therapeutically equivalent to PF Prism C.V.'s marketed product, Bosulif Tablets, 400 mg. Bosutinib is a vital kinase inhibitor used in treating adult patients diagnosed with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). Its indications include newly-diagnosed patients and those with resistance or intolerance to prior therapies, as well as advanced-stage CML patients.
Market Potential and Company Milestones
The 400 mg strength of Bosutinib Tablets represents a significant lifecycle opportunity for the molecule. IQVIA data indicates the U.S. market for these tablets was an estimated $251 million for the twelve months ending September 2025. This approval adds to Alembic Pharma's extensive portfolio, bringing its cumulative USFDA ANDA approvals to 232, comprising 212 final and 20 tentative nods. The company has previously achieved final USFDA approvals for Bosutinib Tablets in 100 mg and 500 mg strengths.
Financial Performance
Recent financial results highlight Alembic Pharma's robust performance. The company reported a 21% year-on-year increase in consolidated net profit, reaching ₹185 crore from ₹153 crore in the prior year. Revenue saw a 16% surge to ₹1,910 crore. Earnings Before Interest, Taxes, Depreciation, and Amortization (EBITDA) grew by 32% year-on-year to ₹315.3 crore, with operating margins expanding to 16.5% from 14.5%.
Shares of Alembic Pharmaceuticals were trading down 0.53% at ₹795.70 as of 12:25 pm. The stock has experienced a 9.26% decline over the past month.