Alembic Pharmaceuticals shares jump 3% as US FDA tentatively approves Larotrectinib capsules

At around 2:22 PM, the stock was trading 0.24% higher at ₹739 per equity share. The scrip has lost 7% over the month and 12% on a year-to-date (YTD) basis.

While the share hit a 52-week high of ₹1,107.90 apiece on June 30, 2025, it touched a year’s low of ₹635.80 on March 23, 2026.

US FDA approval for Larotrectinib Capsules

According to a regulatory filing, the US FDA tentatively approved its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules, 25 mg and 100 mg.

Upon final approval of the ANDA by the US FDA, Alembic may be eligible for 180 days of generic marketing exclusivity in the US, the company added.

“Based on the most recent update to the FDA’s online Paragraph IV database listings, Alembic is the sole first applicant to have filed its ANDA for Larotrectinib Capsules (25 mg and 100 mg), containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act,” the filing read.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals (Bayer), the firm stated.

Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

How big is the Larotrectinib market?

Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of $91 million for the twelve months ending March 2026, according to IQVIA data, as cited by Alembic Pharmaceuticals.

With the latest tentative approval, Alembic has a cumulative total of 241 ANDA approvals, including 221 final approvals and 20 tentative approvals from the US FDA.

Q4 results

Alembic Pharmaceuticals reported a 29% year-on-year (Y-o-Y) surge in its consolidated net profit to ₹202 crore in the March quarter of FY26, compared with ₹157 crore in the year-ago period.

Its revenue from operations increased 4.4% YoY to ₹1,848 crore during the quarter, as against ₹1,770 crore in the fourth quarter of FY25.

Alembic Pharmaceuticals has a total market capitalisation of ₹14,673.44 crore as of June 11, 2026, according to data on the NSE.