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Lupin receives U.S. FDA approval for Extended Phenytoin Sodium Capsules USP

Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced that it has received approval for its Extended Phenytoin Sodium Capsules USP, 100 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Dilantin® 100 mg, of Parke-Davis, division of Pfizer Inc.

Lupin’s Extended Phenytoin Sodium Capsules USP, 100 mg, are indicated for:

  • Treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures
  • Prevention and treatment of seizures occurring during or following neurosurgery
Extended Phenytoin Sodium Capsules USP,100 mg (RLD: Dilantin®) had annual sales of approximately USD 105 million in the U.S. (IQVIA MAT June 2019).

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 8th largest generics pharmaceutical company by revenues (31st Mar 2019, Bloomberg LTM) respectively. The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Jun 2019); 3rd largest Indian pharmaceutical company by global revenues (31st Mar 2019, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 6th largest company in the Indian Pharmaceutical Market (IQVIA MAT Jun 2019).

For the financial year ended 31st March 2019, Lupin’s Consolidated sales and Net profits were at Rs. 163,694 million (USD 2.34 billion) and Rs. 9,466 million (USD 136 million) respectively. Please visit http://localhost/lupin   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 –

Arvind Bothra Head – Investor Relations and M&A / Corporate Communications Email: arvindbothra@lupin.com Ph: +91-22-66408237

*Safe Harbor Statement

 Dilantin® is a registered trademark of a Pfizer Inc. group company

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