August 28, 2016 5:24 AM ET

Pharmaceuticals

Company Overview of Lupin Pharmaceuticals, Inc.

Company Overview

Lupin Pharmaceuticals, Inc. develops and manufactures branded and generic pharmaceutical products for healthcare professionals and patients in India and the United States. It offers generic pharmaceutical products in the areas of oral and injectable cephalosporins; cardiovascular; controlled release ANDA's; and paragraph IV's. It also offers fermentation products; Suprax, an anti-infective product available in tablets and suspension formulations in pediatric and other physician practices for children; cephalosporin API’s; and ACE-inhibitors and cholesterol reducing agents. Lupin Pharmaceuticals, Inc. was founded in 2003 and is based in Baltimore, Maryland. The company has plants in Mandideep...

111 South Calvert Street

Harborplace Tower

21st Floor

Baltimore, MD 21202

United States

Founded in 2003

Phone:

866-587-4617

Fax:

866-587-4627

Key Executives for Lupin Pharmaceuticals, Inc.

Chief Executive Officer and Managing Director
Age: 48
Compensation as of Fiscal Year 2016.

Lupin Pharmaceuticals, Inc. Key Developments

Lupin Pharmaceuticals Inc. Receives Tentative Approval for Generic Lexiva® Tablets, 700 mg from US FDA

Lupin Limited (Lupin) announced that its US subsidiary, Lupin Pharmaceuticals Inc. has received tentative approval from the United States Food and Drug Administration (FDA) to market a generic equivalent of ViiV Healthcare's (ViiV) Lexiva® Tablets, 700 mg (Fosamprenavir Calcium Tablets, 700 mg). This product was filed from Lupin's Goa formulations manufacturing facility. Lupin's Fosamprenavir Calcium Tablets, 700 mg are the AB rated generic equivalent of ViiV Healthcare's Lexiva® Tablets. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Lexiva® Tablets had US sales of USD 71.6 million (IMS MAT March 2016).

Lupin Pharmaceuticals Inc. Launches Generic Ortho Tri-Cyclen Tablets in the US

Lupin Limited announced that Lupin Pharmaceuticals Inc. has launched its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg having received an approval from the United States Food and Drug Administration (FDA) earlier to market a generic version of Janssen Pharmaceuticals, Inc.'s Ortho Tri-Cyclen Tablets. Lupin's Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg are the AB rated generic equivalent of Janssen Pharmaceuticals, Inc.'s Ortho Tri-Cyclen Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg). It is indicated for use by females of reproductive potential to prevent pregnancy.

Lupin and Lupin Pharmaceuticals Announce Re-Introduction of Methergine® (Methylergonovine Maleate) Oral Tablets 0.2 mg for Prevention and Management of Postpartum Hemorrhage

Lupin Limited and Lupin Pharmaceuticals, Inc. have announced the re-introduction of Methergine® (methylergonovine maleate) Oral Tablets 0.2 mg for the prevention and management of postpartum hemorrhage (PPH). Methergine® is the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH, according to guidelines issued by the American Congress of Obstetricians and Gynecologists (ACOG). More than half of all maternal deaths occur within 24 hours of birth, most commonly from excessive bleeding, and rates of maternal morality continue to rise in the USiv where PPH is a leading cause of pregnancy complicationsv. One area of need is further physician education around ascertaining accurate blood loss -- a barrier to optimal care. PPH is defined as blood loss in excess of 500 mL after vaginal delivery or 1000 mL after cesarean delivery, and according to the Association of Women's Health Obstetric and Neonatal Nurses, visual estimation of blood loss is consistently underestimated for volumes over 1000 mL and usually overestimated for smaller volumes. Underestimation of blood loss can lead to the delay of life-saving interventions, while overestimation can lead to costly, unnecessary treatments, such as blood transfusions. A semi-synthetic ergot alkaloid, Methergine is indicated for routine management of uterine atony, hemorrhage and subinvolution of the uterus following delivery of the placenta, and for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. Methergine provides specific and rapid (onset of action under 10 minutes) uterotonic action on the smooth muscle of the uterus to increase contractions, resulting in restricting blood loss. The Methergine dosing schedule is one tablet (0.2 mg) three or four times daily in the puerperium for a maximum of one week. The most common adverse event is hypertension associated in several cases with seizure and/or headache. Methylergonovine maleate is available as an intramuscular injection or as an oral tablet; Lupin acquired oral methylergonovine maleate earlier this year.

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