SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Alembic Pharmaceuticals gets USFDA’s tentative nod for Larotrectinib Capsules

11 Jun 2026 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Larotrectinib Capsules, 25 mg and 100 mg. 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. (Bayer). 

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.

Based on the most recent update to the USFDA’s online Paragraph IV database listings, the company 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. Upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the U.S.

Larotrectinib Capsules, 25 mg and 100 mg, have an estimated market size of $91 million for twelve months ending March 2026 according to IQVIA. The company has a cumulative total of 241 ANDA approvals (221 final approvals and 20 tentative approvals) from USFDA.

Alembic Pharmaceuticals is involved in manufacturing and marketing of India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.

Alembic Pharma Share Price

739.95 4.95 (0.67%)
12-Jun-2026 15:31 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1803.75
Dr. Reddys Lab 1273.80
Cipla 1386.45
Zydus Lifesciences 1103.00
Lupin 2292.00
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through: