Alembic Pharma gets USFDA nod for thyroid disorder and cancer treatment drug

Alembic Pharmaceuticals Ltd. on Friday, May 22, said it has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Levothyroxine Sodium Tablets USP across multiple dosage strengths.

The approved product is therapeutically equivalent to AbbVie Inc.’s Synthroid Tablets and is available in strengths ranging from 25 mcg to 300 mcg.

Alembic Pharma said Levothyroxine sodium tablets are used as replacement therapy for congenital or acquired hypothyroidism and are also indicated as an adjunct treatment in certain thyroid cancer cases.

According to IQVIA data cited by the company, the approved product has an estimated market size of $1.87 billion in the US for the 12 months ended March 2026.

With this approval, Alembic Pharmaceuticals now has a cumulative total of 239 ANDA approvals from the USFDA, including 220 final approvals and 19 tentative approvals.

Last week, the company received a tentative approval from the USFDA for its ANDA for Darolutamide Tablets, 300 mg, an oral medication used to treat specific types of advanced prostate cancer. The drug had an estimated market size of $3.16 billion as of March 2026 in the US.

The pharma company reported a 29% year-on-year growth in consolidated net profit for Q4FY26 to ₹202 crore from ₹157 crore in the previous year. Revenue rose 4.4% to ₹1,848 crore from ₹1,770 crore in the year-ago period. EBITDA declined 16.2% YoY to ₹228 crore from ₹272 crore, while EBITDA margin narrowed to 12.3% from 15.4% last year.

Shares of Alembic Pharmaceuticals gained following the USFDA approval and were trading 0.87% up at ₹755.45 as of 11.22 am. The stock has, however, declined 22% over the last year.