Alembic Pharmaceuticals Limited has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules in strengths of 25 mg and 100 mg. The approval marks another milestone in the company’s expanding portfolio of complex generic products for regulated international markets.
The approved ANDA references Bayer Healthcare Pharmaceuticals’ Vitrakvi® Capsules and has been determined to be therapeutically equivalent to the reference listed drug. Larotrectinib is a kinase inhibitor used in the treatment of adult and pediatric patients with specific solid tumors that exhibit neurotrophic receptor tyrosine kinase (NTRK) gene fusions and meet defined clinical criteria.
According to market data for the twelve months ending March 2026, the U.S. market for Larotrectinib Capsules is estimated at approximately US$91 million, highlighting a significant opportunity in the specialty oncology segment. A notable aspect of the filing is Alembic’s position as the sole first applicant to submit an ANDA containing a Paragraph IV certification for the product under the Hatch-Waxman framework. Subject to final approval from the USFDA and fulfillment of applicable regulatory requirements, the company could become eligible for 180 days of generic market exclusivity in the United States.
The development reinforces Alembic’s strategy of focusing on differentiated and value-added generic opportunities while strengthening its presence in highly regulated pharmaceutical markets. Over the years, the company has steadily expanded its research, development and manufacturing capabilities to support a broad portfolio of products across multiple therapeutic categories.
Alembic now holds a cumulative total of 241 ANDA approvals from the USFDA, including 221 final approvals and 20 tentative approvals. This achievement reflects the company’s sustained commitment to quality, regulatory compliance and product development.
Founded in 1907, Alembic Pharmaceuticals has evolved into a globally recognized pharmaceutical organization with a strong presence in branded formulations, generic medicines and active pharmaceutical ingredients. Its vertically integrated operations and advanced manufacturing facilities support the production of high-quality healthcare solutions for markets worldwide.
The company’s manufacturing sites are approved by leading international regulatory agencies, including the USFDA, enabling it to serve patients across numerous countries. In India, Alembic remains one of the leading branded generics companies, supported by an extensive field force and a portfolio of well-established healthcare brands.
