“Embedded in Lupin is a formula for growth which fuels creativity, performance and innovation”
It was Dr. Desh Bandhu Gupta’s vision and passion which helped him grow a small dream into a large company with a global footprint.
The most advanced pharmaceutical product development
Developing new chemical entities for focused therapy areas
Producing quality medicines in areas of
Producing high quality affordable
and accessible biologics
Lupin receives sANDA approval from U.S. FDA for Levothyroxine Sodium Tablets USP
to be considered AB rated to Reference Listed Drug, UNITHROID®
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 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®.
Lupin’s Levothyroxine Sodium Tablets are indicated for:
Levothyroxine Sodium Tablets USP (RLD: UNITHROID® and SYNTHROID®) had annual sales of approximately USD 2581 million in the US (IQVIA MAT June 2019).
About Lupin Limited
Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.
Lupin is the 8th largest generics pharmaceutical company by revenues (31st Mar 2019, Bloomberg LTM) respectively. The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2019, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).
For the financial year ended 31st March, 2019, Lupin’s Consolidated sales and Net profits were at Rs. 163,694 million (USD 2.34 billion) and Rs. 9,466 million (USD 136 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinglobal
CIN: L24100MH1983PLC029442 Registered Office: Lupin Ltd, 3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055.
For further information or queries please contact –
VP – Corporate Communications
Ph: +91-22-66402531 / 8291013225
Head – Investor Relations
*Safe Harbor Statement
UNITHROID® is the registered trademark of Jerome Stevens Pharmaceuticals Inc.
SYNTHROID® is the registered trademark of AbbVie Inc.