Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Venetoclax Tablets in strengths of 10 mg, 50 mg and 100 mg. The approved generic tablets are therapeutically equivalent to Venclexta Tablets, marketed by AbbVie Inc. The approval adds another product to Alembic’s portfolio of generic medicines for the US market.
Venetoclax tablets are indicated for the treatment of adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The medicine is also indicated, in combination with azacitidine, decitabine or low-dose cytarabine, for treating newly diagnosed acute myeloid leukaemia (AML) in adults aged 75 years or older, or in patients with comorbidities that prevent the use of intensive induction chemotherapy. The approved product labelling provides details of the indications and conditions of use.
Alembic was among the first applicants to submit a substantially complete ANDA containing a Paragraph IV certification for Venetoclax Tablets in the three strengths. Following the final approval, the company may be eligible for 180 days of generic drug exclusivity, subject to applicable regulatory provisions.
According to IQVIA data, the US market for Venetoclax Tablets in 10 mg, 50 mg and 100 mg strengths was estimated at US$1,584 million for the 12 months ended June 2026. With this approval, Alembic’s cumulative number of ANDA approvals from the USFDA has reached 248. This includes 228 final approvals and 20 tentative approvals.
The approval is part of the company’s ongoing expansion of its generic pharmaceutical portfolio in the United States. Alembic develops and manufactures pharmaceutical formulations and active pharmaceutical ingredients for domestic and international markets. Its research, development and manufacturing operations support product development and regulatory submissions across multiple markets.
Alembic Pharmaceuticals Limited is a vertically integrated pharmaceutical company engaged in research, development, manufacturing and marketing of generic medicines. Established in 1907 and headquartered in India, the company has operations across several international markets and is listed on Indian stock exchanges.
Its manufacturing and research facilities are approved by regulatory authorities in several developed markets, including the USFDA. Alembic is also a major participant in India’s branded generics market, where its products are marketed through a field force of more than 5,800 employees and are prescribed across a range of therapeutic areas.
