By: IPP Bureau
Last updated : May 22, 2026 2:26 pm
approved product is therapeutically equivalent to Synthroid of AbbVie Inc. and is indicated for the treatment of congenital or acquired hypothyroidism,
Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP across multiple strengths ranging from 25 mcg to 300 mcg.
The approved product is therapeutically equivalent to Synthroid of AbbVie Inc. and is indicated for the treatment of congenital or acquired hypothyroidism, as well as for use alongside surgery and radioiodine therapy in certain thyroid cancer management protocols.
According to IQVIA data for the 12 months ending March 2026, the product has an estimated US market size of US$ 1.869 billion, making it a significant addition to Alembic’s US generics portfolio.
With this approval, Alembic now holds a cumulative total of 239 ANDA approvals from the USFDA, comprising 220 final approvals and 19 tentative approvals, further strengthening its presence in the highly competitive US pharmaceutical market.