Lupin Receives FDA Approval for Generic Klor-Con® Extended-Release Tablets


Mumbai, August 10, 2016: Pharma Major Lupin Limited announced today that its US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. (collectively Lupin) has received final approval for its Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) from the United States Food and Drug Administration (FDA) to market a generic equivalent of Upsher-Smith Labs Klor-Con® Extended-Release Tablets, 8 mEq and 10 mEq.

Lupin’s Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg) are the AB rated generic equivalent of Upsher-Smith Labs Klor-Con® Extended-Release Tablets, 8 mEq and 10 mEq. It is an electrolyte replenisher indicated for:

  • The therapeutic use of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis.
  • The prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.

Klor-Con® Extended-Release Tablets, 8 mEq and 10 mEq had US sales of USD 101.3million (IMS MAT June 2016)

About Lupin Limited

Lupin is an innovation led transnational pharmaceutical company producing and developing 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 5th largest generics player in the US (5.51% generic market share by prescriptions – IMS Health, National Prescription Audit, MAT March 2016) and the 2nd largest Indian pharmaceutical company by market capitalization. The Company is also the 9th largest generic pharmaceutical player in Japan and the 4th largest generic pharmaceutical company in South Africa (IMS Health, March 2016).

For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs. 136,539 million (USD 2.09 billion) and Rs. 22,607 million (USD 345 million) respectively. Please visit http://www.lupin.com for more information. You could also follow us on Twitter – www.twitter.com/lupinlimited

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 –
Shamsher Gorawara
Head – Corporate Communications
Lupin Limited
Ph: +91 98 20 338 555
Email: shamshergorawara@lupin.com

*Safe Harbor Statement

Klor-Con® is the registered trademark of Upsher-Smith Laboratories Inc.