Alembic Pharmaceuticals Ltd announced on Friday that it has received final approval from the US Food & Drug Administration (USFDA) for its generic version of levothyroxine sodium tablets. According to the company's regulatory filing, the approval covers the Abbreviated New Drug Application (ANDA) for levothyroxine sodium tablets in various strengths ranging from 25 mcg to 300 mcg. The approved ANDA is therapeutically equivalent to the reference listed drug product, Synthroid tablets of AbbVie, Inc. As per the latest reports, the tablets are available in 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 strengths, strengthening Alembic's US generics portfolio and thyroid drug line-up. This development is significant for patients seeking affordable treatment options in the substantial market for these tablets.
As reported by Alembic Pharmaceuticals, levothyroxine sodium tablets are indicated as a replacement therapy for primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. The tablets also serve as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. The company emphasized that the tablets are indicated for both replacement therapy and adjunctive treatment in thyroid conditions, with detailed indications available in the label.
According to Alembic's regulatory filing, levothyroxine sodium tablets have an estimated market size of $1,869 million for the 12 months ended March 2026, as cited from IQVIA data. This substantial market opportunity represents a significant addressable market for the company's generic version of the thyroid medication. The approval provides Alembic with access to this established therapeutic segment in the US market, strengthening its position in the competitive generics landscape and offering patients an affordable alternative to branded treatments.
With this latest approval, Alembic now holds a cumulative total of 239 ANDA approvals from the USFDA, comprising 220 final approvals and 19 tentative approvals. This significant milestone further strengthens the company's presence in the highly competitive US pharmaceutical market. The approval provides Alembic with access to this established therapeutic segment in the US market, strengthening its position in the competitive generics landscape and offering patients an affordable alternative to branded treatments.
Across business segments, the quarter showed mixed performance. The India Branded Business delivered 4% year-on-year growth, reaching ₹5.68 Bn in revenue, with the company ranked 21st in the Indian Pharmaceutical Market (IPM) and holding a 1.2% market share. The US Formulation business grew 11% year-on-year to ₹5.64 Bn, supported by 6 product launches in the quarter. The Ex-US Generics business recorded a de-growth of -2% year-on-year to ₹3.69 Bn, attributed to a higher base effect and one-off variances. The API business grew 2% to ₹3.47 Bn, led by strong volumes, though tempered by pricing challenges. The Animal Health segment was a standout performer, recording 27% year-on-year growth with quarterly revenue of ₹1,241 Mn, driven by its established portfolio in Livestock, Poultry, and Companion Animal segments.
