Alembic Pharmaceuticals receives USFDA approval for Levothyroxine Sodium Tablets

Kinjal — Fri, 22 May 2026 05:29:09 +0000

Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP in multiple dosages, including 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. This approval confirms the therapeutic equivalence of Alembic’s product to the reference listed drug, Synthroid Tablets, manufactured by AbbVie, Inc.

Levothyroxine Sodium Tablets are prescribed as a replacement therapy for various forms of hypothyroidism, including primary, secondary, and tertiary hypothyroidism, whether congenital or acquired. Additionally, these tablets are utilised as an adjunct to surgery and radioiodine therapy in managing thyrotropin-dependent well-differentiated thyroid cancer.

According to IQVIA, the market size for Levothyroxine Sodium Tablets USP is estimated to be US$ 1,869 million for the twelve months ending March 2026. This approval adds to Alembic’s impressive portfolio of 239 ANDA approvals from the USFDA, comprising 220 final approvals and 19 tentative approvals.

Alembic Pharmaceuticals Limited, established in 1907, is a vertically integrated research and development pharmaceutical company headquartered in India. It is a publicly listed entity known for manufacturing and marketing generic pharmaceutical products globally. The company operates state-of-the-art research and manufacturing facilities that have received approvals from regulatory authorities in several developed countries, including the USFDA. Alembic is a leader in branded generics in India, with a well-recognised portfolio marketed through a field force of over 5,500 professionals.

For further information, Alembic Pharmaceuticals can be contacted via their website at www.alembicpharmaceuticals.com, or through Ajay Kumar Desai at +91 22-66953681 or via email at ajay.desai@alembic.co.in.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

Levothyroxine Sodium | Business Upturn

Alembic Pharmaceuticals receives USFDA approval for Levothyroxine Sodium Tablets