Alembic Pharmaceuticals Receives USFDA Final Approval for Levothyroxine Sodium Tablets
Alembic Pharmaceuticals Limited announced that it has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Levothyroxine Sodium Tablets USP.The approved ANDA covers multiple strengths of the drug, 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.
According to the company announcement, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Synthroid Tablets, manufactured by AbbVie, Inc.
Levothyroxine sodium tablets are medically indicated as a replacement therapy for primary, secondary, and tertiary congenital or acquired hypothyroidism. They are also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer, with label guidelines providing detailed indications.
Key Drug Details and Market Context
The following table outlines the specific strengths covered by the USFDA approval:| Drug Product | Strengths Covered (mcg) |
|---|---|
| Levothyroxine Sodium Tablets USP | 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 |
The market for Levothyroxine Sodium Tablets USP is substantial, with an estimated market size of US$ 1,869 million for the twelve months ending March 2026, according to IQVIA.
Alembic Pharmaceuticals Limited, a vertically integrated pharmaceutical company, noted that the company has a cumulative total of 239 ANDA approvals from the USFDA, including 220 final approvals and 19 tentative approvals.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited are edging higher to ₹757.9 as of 11:04 AM, rallying 1.20% in live trading today. The stock is seeing strong intraday activity, trading on a robust volume of 86,795 shares.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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