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Lupin receives FDA approval for generic Tamiflu® for Oral Suspension

 

Mumbai, Baltimore, February 21, 2018: Pharma major Lupin announced that it has received final approval for its Oseltamivir Phosphate for Oral Suspension from the United States Food and Drug Administration (FDA) to market the generic version of Hoffman-La Roche, Inc.’s Tamiflu for Oral Suspension, 6 mg/mL. Lupin shall commence promoting the product shortly.

Lupin’s Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is AB rated generic equivalent of Hoffman-La Roche, Inc’s Tamiflu® for Oral Suspension, 6 mg (base)/mL. Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is indicated for i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and ii) prophylaxis of influenza A and B in patients 1 year and older.

Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL had annual sales of approximately USD 358 million in the US (IQVIA MAT October 2017).

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, Paediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 11th and 7th largest generics pharmaceutical company by market capitalization (December 31st, 2017, Bloomberg) and revenues (September 30th, 2017, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT December 2017); 2nd largest Indian pharmaceutical company by global revenues (September 30th, 2017, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in Indian Pharmaceutical Market (IQVIA MAT December 2017).

For the financial year ended 31st March, 2017, Lupin’s consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 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

Or

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

*Safe Harbor Statement

Tamiflu® is a registered trademark of Hoffman-La Roche Inc.