Alembic Pharmaceuticals has received tentative approval from the United States Food and Drug Administration (USFDA) for Larotrectinib Capsules, 25 mg and 100 mg. This regulatory clearance positions the company as the sole first applicant for the product, potentially granting it 180 days of marketing exclusivity in the US upon final approval. The approval covers the Abbreviated New Drug Application (ANDA) for the generic version of Bayer Healthcare Pharmaceuticals Inc.'s Vitrakvi Capsules.

Regulatory Approval Details

The tentative USFDA approval is for Larotrectinib Capsules in strengths of 25 mg and 100 mg. The product 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. The key details of this approval are outlined below:

Significance for US Market Expansion

The tentative approval from the USFDA for Larotrectinib Capsules underscores Alembic Pharmaceuticals' continued focus on expanding its generics pipeline in the United States. With an estimated market size of $91 million, the product represents a meaningful addition to the company's US-facing portfolio. Alembic has a cumulative total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.

Alembic Pharmaceuticals Limited has fixed Wednesday, July 29, 2026, as the record date to determine shareholder eligibility for the dividend payment for the financial year 2025-26, subject to approval at the upcoming Annual General Meeting (AGM). The 16th AGM is scheduled for Wednesday, August 5, 2026, at 4:00 P.M. IST via video conferencing. The meeting will be conducted in compliance with the Companies Act, 2013, and the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

The Board emphasized that dividend payments will be made exclusively through electronic mode. Shareholders holding physical share certificates must ensure their folios are updated with the Registrar and Transfer Agent, MUFG Intime India Pvt. Ltd., by Friday, July 24, 2026. Required updates include the Permanent Account Number (PAN), contact details, mobile number, bank account details, and specimen signature. Failure to update these details may result in a delay or inability to receive the dividend.

The Annual Report and Notice of AGM will be sent only to members whose email addresses are registered with the company or depositories. These documents will also be available on the company's website and the websites of BSE Limited and National Stock Exchange of India Limited. The notice will additionally be accessible on the National Securities Depository Limited website.

In accordance with the Income Tax Act, 2025, the company will deduct tax at source (TDS) on dividends at prescribed rates. The applicable TDS rate depends on the shareholder's residential status and the documentation submitted. Shareholders are advised to update their PAN and submit relevant forms, such as Form 121 / 41 or Tax Residency Certificates, to the Registrar to avoid higher tax deductions.