SEBI Reg. Investment Advisor

Download App

MoneyWorks4Me

Lupin receives sANDA approval from USFDA for Levothyroxine Sodium Tablets

20 Sep 2019 Evaluate

Lupin has received approval for its supplemental Abbreviated New Drug Application (sANDA) for Levothyroxine Sodium Tablets USP, 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, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of UNITHROID 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, manufactured by Jerome Stevens Pharmaceuticals Inc.

The company’s Levothyroxine Sodium Tablets USP, 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 was originally approved on January 18, 2019 as generic equivalent of SYNTHROID 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, manufactured by ABBVIE Inc.

With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 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 are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID. Levothyroxine Sodium Tablets USP (RLD: UNITHROID and SYNTHROID) had annual sales of approximately $2581 million in the US (IQVIA MAT June 2019). The company’s Levothyroxine Sodium Tablets are indicated for Hypothyroidism and Pituitary Thyrotropin Suppression.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

Lupin Share Price

2377.90 -81.85 (-3.33%)
08-May-2026 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1847.30
Dr. Reddys Lab 1293.25
Cipla 1347.70
Zydus Lifesciences 938.90
Lupin 2377.90
View more..

About MoneyWorks4Me

MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.

Our Vision

To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.

What Makes MoneyWorks4Me Different

Our Approach: Ensuring compounding work its magic on client portfolio.

MoneyWorks4Me ensures this through:

×