Alembic Pharma receives USFDA nod for generic Synthroid tablets used for thyroid disorder treatment
Sarthak Kumar
Alembic Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Levothyroxine Sodium Tablets USP, a widely prescribed medication used for treating thyroid-related disorders.
The approval covers multiple dosage strengths ranging from 25 mcg to 300 mcg. The company said the approved product is therapeutically equivalent to AbbVie’s reference listed drug Synthroid Tablets.
Levothyroxine is primarily used as hormone replacement therapy for patients suffering from hypothyroidism, a condition in which the thyroid gland does not produce sufficient thyroid hormone. The medication also plays a role in treating certain thyroid cancers and is used alongside surgery and radioiodine therapy in some cases.
According to IQVIA data cited by the company, the approved product has an estimated market size of US$1.869 billion for the twelve months ended March 2026 in the United States.
With this latest approval, Alembic Pharmaceuticals’ cumulative USFDA ANDA approvals have reached 239, comprising 220 final approvals and 19 tentative approvals.
Headquartered in Vadodara, Alembic Pharmaceuticals is engaged in the research, development, manufacturing and marketing of generic pharmaceutical products across global markets.
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