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.

Alembic Pharmaceuticals has filed writ petitions with the Gujarat High Court challenging supplementary invoices worth ₹421.68 crores issued by Madhya Gujarat Vij Company Limited (MGVCL). The pharmaceutical company disclosed this legal action under Regulation 30 of SEBI Listing Regulations.

Legal Challenge Details

Alembic Pharmaceuticals has approached the High Court of Gujarat, Ahmedabad, seeking to quash and set aside the disputed supplementary invoices related to the installation of rooftop solar PV system. The legal action represents a significant dispute between the pharmaceutical manufacturer and the Gujarat state electricity distribution company.

Financial Implications

The company has clarified that the financial implications of this litigation will depend entirely on the final outcome of the court proceedings. Currently, there is no immediate financial liability pending the resolution of the matter. The disputed amount of ₹421.68 crores represents a substantial sum that could impact the company's financials depending on the court's decision.

Regulatory Compliance

Alembic Pharmaceuticals made this disclosure in compliance with SEBI regulations, specifically under Regulation 30 of the Listing Obligations and Disclosure Requirements Regulations, 2015. The company provided detailed information as required under Schedule III of the Listing Regulations.

Current Status

The matter remains sub-judice with the Gujarat High Court. The company has emphasized that the invoiced amount is disputed, and the final monetary impact will only be determined once the litigation is conclusively resolved. This legal challenge highlights ongoing disputes in the renewable energy sector, particularly regarding billing and installation charges for solar power systems.