Alembic Pharmaceuticals Limited has announced a board meeting scheduled for February 5, 2026, to review and approve its unaudited financial results for the third quarter of fiscal year 2026. The meeting will focus on the financial performance for the quarter and nine months ended December 31, 2025.

Board Meeting Details

The pharmaceutical company has formally notified both the Bombay Stock Exchange and National Stock Exchange of India about the upcoming board meeting. The notification, dated January 20, 2026, was signed by Company Secretary Manisha Saraf and submitted to fulfill regulatory compliance requirements under applicable regulations.

Trading Window Restrictions

In accordance with the company's Code of Conduct for Regulating, Monitoring and Reporting of Trading by Designated Persons and their Immediate Relatives, Alembic Pharmaceuticals has implemented trading window restrictions. The trading window for dealing in the company's securities was closed effective January 1, 2026.

The company has specified that the trading window will reopen 48 hours after the official declaration of the financial results. This measure ensures compliance with insider trading regulations and maintains market integrity during the financial results announcement period.

Regulatory Compliance

The board meeting announcement demonstrates Alembic Pharmaceuticals' adherence to stock exchange regulations and corporate governance standards. The company has provided advance notice to both major Indian stock exchanges, allowing investors and market participants to prepare for the upcoming financial disclosure.

The pharmaceutical company's registered office is located at Alembic Road, Vadodara, and it maintains regular communication with stakeholders through its official website and designated email channels for investor relations and corporate communications.

Alembic Pharmaceuticals Limited announced on January 12, 2026, that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Bosutinib Tablets, 400mg. This regulatory milestone represents another significant achievement for the pharmaceutical company in expanding its oncology portfolio in the US market.

USFDA Approval Details

The company received tentative approval for its supplemental Abbreviated New Drug Application (sANDA) for Bosutinib Tablets, 400mg. The approved product is therapeutically equivalent to the reference listed drug product Bosulif Tablets, 400mg, manufactured by PF Prism C.V.

Therapeutic Applications

Bosutinib is a kinase inhibitor with specific indications for cancer treatment. The drug is indicated for treating adult patients with chronic phase Ph+ chronic myelogenous leukemia (CML), whether newly-diagnosed or resistant or intolerant to prior therapy. Additionally, it is approved for adult patients with accelerated or blast phase Ph+ CML who have shown resistance or intolerance to prior therapy.

Alembic Pharmaceuticals had previously received final approval for its ANDA Bosutinib Tablets in 100mg and 500mg strengths, making the 400mg strength a complementary addition to its existing product line.

Market Opportunity

The market potential for this product appears substantial. According to IQVIA data, Bosutinib Tablets, 400mg, have an estimated market size of US$251.00 million for the twelve months ending September 2025. This represents a significant commercial opportunity for Alembic Pharmaceuticals in the competitive US generic pharmaceuticals market.

ANDA Portfolio Expansion

With this latest tentative approval, Alembic Pharmaceuticals has strengthened its regulatory portfolio in the United States. The company now holds a cumulative total of 232 ANDA approvals from the USFDA.

This extensive portfolio demonstrates the company's consistent ability to navigate the complex USFDA approval process and maintain compliance with stringent regulatory standards. The combination of final and tentative approvals provides Alembic with a robust pipeline of products for the US market.