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Lupin receives FDA approval for generic Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg

 

Mumbai, Baltimore, June 14, 2018: Pharma major Lupin announced that it has received final approval for its Drospirenone, Ethinyl Estradiol,  Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Bayer HealthCare Pharmaceutical Inc.’s (Bayer) Beyaz® Tablets.

Lupin’s Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, are the generic equivalent of Bayer’s Beyaz® Tablets. It is indicated for use by women to:

  • prevent pregnancy;
  • treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception;
  • treat moderate acne for women at least 14 years old, only if the patient desires an oral contraceptive for birth control; and
  • raise folate levels in women who choose to use an oral contraceptive for contraception

Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg had annual sales of approximately USD 82.2 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 December 2017, 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 December 2017, 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 were at Rs. 155,598 million (USD 2.41 billion) and Rs. 2,513 million (USD 39 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

Beyaz® is a registered trademark of Bayer Aktiengesellschaft