Alembic Pharmaceuticals Limited today announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP in strengths of 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. The approved product is therapeutically equivalent to the reference listed drug, Synthroid Tablets, marketed by AbbVie Inc.. Levothyroxine sodium tablets are widely prescribed for the treatment of hypothyroidism and play a critical role in hormone replacement therapy for patients with thyroid disorders.
Levothyroxine sodium tablets are indicated for replacement therapy in patients suffering from primary, secondary and tertiary congenital or acquired hypothyroidism. In addition, the medication is used as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. The approval strengthens Alembic’s growing presence in the highly regulated US generics market and reinforces the company’s commitment to expanding access to quality medicines globally.
According to IQVIA data for the twelve months ending March 2026, the Levothyroxine Sodium Tablets market in the United States is estimated at approximately US$1.87 billion, making it one of the significant segments within the thyroid therapy market. With this approval, Alembic Pharmaceuticals has further strengthened its USFDA-approved product portfolio. The company now holds a cumulative total of 239 ANDA approvals from the USFDA, including 220 final approvals and 19 tentative approvals.
Founded in 1907, Alembic Pharmaceuticals has evolved into a vertically integrated research-driven pharmaceutical company with a strong global footprint. Headquartered in India, the company manufactures and markets generic pharmaceutical products across multiple international markets. Its manufacturing and research facilities are approved by several leading regulatory authorities, including the USFDA.
Alembic continues to maintain a strong position in the Indian branded generics market through an extensive portfolio of products supported by a field force of more than 5,500 professionals. The company’s brands enjoy wide recognition among healthcare professionals and patients alike.
The latest approval reflects Alembic’s sustained focus on research, product development and regulatory compliance, while supporting the company’s long-term strategy of expanding its portfolio in complex and high-value therapeutic categories. Through continued investment in innovation and manufacturing excellence, Alembic aims to address evolving healthcare needs and improve patient access to affordable treatment options across global markets.
