Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated May 22, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Levothyroxine Sodium Tablets USP".
APLLTD · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Alembic Pharmaceuticals has received final approval from the USFDA for its generic drug Levothyroxine Sodium Tablets USP across 12 dosage strengths (25 mcg to 300 mcg). The drug is therapeutically equivalent to AbbVie's branded product Synthroid Tablets and is used for thyroid hormone replacement therapy in hypothyroidism conditions. The approved ANDA marks Alembic's 239th cumulative ANDA approval from USFDA (220 final and 19 tentative approvals). The US market for this drug is estimated at US$ 1,869 million for the twelve months ending March 2026, indicating a substantial revenue opportunity in a large market segment.
This approval strengthens Alembic's US generics portfolio and opens access to a nearly $1.9 billion market, potentially boosting revenue from US sales and improving market share in the thyroid medication segment.