Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP. The approval spans 12 distinct strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg.
Alembic’s newly approved therapeutic offering is bioequivalent to AbbVie, Inc.’s reference listed drug (RLD), Synthroid Tablets. This major regulatory clearance expands Alembic’s growing US product portfolio, targeting a substantial market. According to IQVIA data, the market size for Levothyroxine Sodium Tablets USP was estimated at US$ 1,869 million for the twelve months ending March 2026. Levothyroxine Sodium Tablets are primarily utilized for the following medical treatments such as Hypothyroidism where it serves as a replacement therapy for congenital or acquired hypothyroidism across primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) classifications. In thyroid cancer management it, functions as an adjunctive treatment alongside surgery and radioiodine therapy to manage thyrotropin-dependent, well-differentiated thyroid cancer.
Patients and healthcare professionals should consult the product label for comprehensive, detailed prescribing information and indications.
With this latest milestone, Alembic has now achieved a cumulative total of 239 ANDA approvals from the USFDA, consisting of 220 final approvals and 19 tentative approvals.
Written By Pragna Biswas
Graphics By Pramit Hazra
