Lupin receives tentative US FDA approval for Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mgn

Mumbai, Baltimore, December 13, 2018 : Pharma major Lupin announced that it has received tentative approval for its Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg from the United States Food and Drug Administration (FDA) to market a generic version of Biogen, Inc’s Tecfidera Capsules, 120 mg and 240 mg.

Lupin’s Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg is the generic version of Biogen, Inc’s Tecfidera Capsules, 120 mg and 240 mg. It is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Tecfidera Capsules, 120 mg and 240 mg had annual sales of approximately USD $3,545.4 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 13^th largest generics pharmaceutical company in terms of market capitalization (30^th September 2018, Bloomberg) and the 8^th largest generics pharmaceutical company in terms of revenues (30^th June 2018, Bloomberg LTM) globally. The Company is the 3^rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT September 2018); 3^rd largest Indian pharmaceutical company by global revenues (30^th June 2018, Bloomberg LTM); 6^th largest generic pharmaceutical player in Japan (IQVIA MAT September 2018) and 5^th largest company in the Indian Pharmaceutical Market (IQVIA MAT September 2018).

For the financial year ended 31^st 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, 3^rd 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

Or

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

Safe Harbor Statement

Tecfidera® is a registered trademark of Biogen MA Inc