Alembic Pharmaceuticals Limited has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Levothyroxine Sodium Tablets USP across multiple strengths ranging from 25 mcg to 300 mcg.

The approved generic drug is therapeutically equivalent to Synthroid tablets manufactured by AbbVie. Levothyroxine sodium tablets are primarily used for the treatment of hypothyroidism and are also prescribed as part of thyroid cancer management therapy.

According to IQVIA data, the approved product has an estimated US market size of USD 1.87 billion for the 12 months ended March 2026.

With this approval, Alembic Pharma’s cumulative USFDA ANDA tally has reached 239, including 220 final approvals and 19 tentative approvals.