Lupin receives FDA approval for generic Hydroxychloroquine Sulfate Tablets USP, 200 mg


Mumbai, Baltimore, July 9, 2018: Pharma major Lupin announced that it has received final approval for its Hydroxychloroquine Sulfate Tablets USP, 200 mg from the United States Food and Drug Administration (FDA) to market a generic version of Concordia Pharmaceuticals, Inc.’s Plaquenil Tablets, 200 mg.

Lupin’s Hydroxychloroquine Sulfate Tablets USP, 200 mg is the generic version of Concordia Pharmaceuticals, Inc.’s Plaquenil Tablets, 200 mg. It is indicated for:

  • the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax
  • the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported
  • the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults
  • the treatment of acute and chronic rheumatoid arthritis in adults

Hydroxychloroquine Sulfate Tablets USP, 200 mg had annual sales of approximately USD 215.3 million in the US (IQVIA MAT April 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 12th and 8th largest generics pharmaceutical company by market capitalization (31st March 2018, Bloomberg) and revenues (31st Mar 2018, Bloomberg LTM) respectively. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT March 2018); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT March 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 – http://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

Plaquenil® is a registered trademark of Concordia Pharmaceuticals, Inc.