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Lupin receives FDA approval for Levothyroxine Sodium Tablets USP

Mumbai, Baltimore: Pharma major Lupin announced that it has received approval for its 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 (FDA) to market a generic version of AbbVie, Inc’s Synthroid Tablets, 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.

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 is the generic version of AbbVie, Inc’s Synthroid Tablets, 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. It is indicated for:

  • Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism
  • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer
Levothyroxine Sodium Tablets, 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 had annual sales of approximately USD 2519.6 million in the US (IQVIA MAT September 2018).

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 13th largest generics pharmaceutical company in terms of market capitalization (30th September 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th June 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT September 2018); 3rd largest Indian pharmaceutical company by global revenues (30th June 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT September 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2018).

For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 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 –

Pooja Thakran VP – Corporate Communications Email: poojathakran@lupin.com Ph: +91-22-66402531 / 8291013225

Arvind Bothra Head – Investor Relations Email: arvindbothra@lupin.com Ph: +91-22-66402137

*Safe Harbor Statement

Synthroid® is a registered trademark of AbbVie, Inc.

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