Alembic Pharmaceuticals shares jumped 3% to ₹739 following the announcement of its USFDA tentative approval for Larotrectinib Capsules. According to Business Standard, the stock movement reflects positive investor sentiment toward the company's regulatory milestone. This approval brings Alembic Pharma's cumulative USFDA tally to 241 ANDA approvals, comprising 221 final approvals and 20 tentative approvals. The company's strong quarterly performance also contributed to the positive market reception, with shares now trading at ₹739 compared to the previous trading level. As per CNBC TV18, the stock was trading 0.24% higher at ₹739 per equity share around 2:22 PM, though it has lost 7% over the month and 12% on a year-to-date basis. Latest trading data shows the stock opened at ₹737.20 and moved in a range of ₹729.50 to ₹759.20 with an average price of ₹744.35 for the day.
According to a regulatory filing, Alembic Pharmaceuticals Ltd. received tentative approval from the US Food and Drug Administration (USFDA) for its generic version of Larotrectinib Capsules in strengths of 25 mg and 100 mg. The approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bayer Healthcare Pharmaceuticals' Vitrakvi Capsules, a kinase inhibitor used to treat certain adult and pediatric patients with solid tumours that carry a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. As reported by the company, "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 approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Vitrakvi Capsules, 25 mg and 100 mg, of Bayer Healthcare Pharmaceuticals Inc.
According to IQVIA data cited by Alembic Pharma, Larotrectinib Capsules recorded estimated annual sales of $91 million in the US for the 12 months ended March 2026. The drug is prescribed for patients whose cancers are metastatic or cannot be safely removed through surgery, and who either have no satisfactory alternative treatment options or whose disease has progressed despite prior treatment. Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that: a) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, b) are metastatic or where surgical resection is likely to result in severe morbidity, and c) have no satisfactory alternative treatments or that have progressed following treatment. Subject to final approval from the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the United States.
According to Business Standard, Alembic Pharmaceuticals reported strong financial results for Q4 FY26, with consolidated net profit jumping 29% year on year to ₹202 crore compared to ₹157 crore in the year-ago period. Revenue from operations grew 4.4% year on year to ₹1,848 crore during the quarter, as against ₹1,770 crore in the fourth quarter of FY25. The company operates as a vertically integrated research and development pharmaceutical company that manufactures and markets generic pharmaceutical products worldwide. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. As per CNBC TV18, Alembic Pharmaceuticals has a total market capitalisation of ₹14,673.44 crore as of June 11, 2026, according to data on the NSE. The company's market capitalisation stands at ₹14,477 crores as of June 11, 2026, with a P/E ratio of 21.6 and dividend yield of 1.64%.
