Mumbai, India and WARREN, NJ, November 29, 2022 /PRNewswire/ — Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) and its wholly owned subsidiary Cipla UNITED STATES Inc. (hereinafter referred to as ‘cipla‘), today announced the launch of Leuprolide Acetate Injection Depot 22.5 mg. The product has been approved by the United States Food and Drug Administration (‘United States FDA‘) based on a New Drug Application (NDA) submitted under the 505(b)(2) regulatory pathway.
Leuprolide Acetate Injection Depot contains 22.5mg of leuprolide acetate for 3 months administration given as a single injection.
It is supplied as lyophilized microspheres in a single-dose vial as a kit with a pre-filled syringe containing 2 ml of 0.8% mannitol solution and an easy-to-use MIXJECT.® transfer device for single dose injection. It is indicated in the palliative treatment of advanced prostate cancer.
Arunesh VermaCEO of Cipla North America, said, “The launch of Leuprolide Acetate Injection Depot reinforces our commitment as an organization to bring high quality, affordable treatments to patients in the United States. Enabling access to high-quality treatments is at the heart of our goal to ‘Take care of life‘. This launch is part of our growth strategy in the complex products segment.”
Active ingredient, route of administration, dosage form and strength are the same as LUPRON DEPOT® 22.5mg, from Abbvie. According to IQVIA, LUPRON DEPOT® 22.5 mg had US sales of approximately $197 million for the 12 month period ending September 2022.
Founded in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics and portfolio deepening in our home markets of India, South Africa, North America, and major regulated and emerging markets. Our strengths in the respiratory, antiretroviral, urological, cardiological, anti-infective and CNS segments are recognized. Our 47 manufacturing sites worldwide produce more than 50 dosage forms and more than 1,500 products using state-of-the-art technology platforms to serve our 86 markets. Cipla is the 3rd the largest in the pharmaceutical industry in India (IQVIA MAT September 22), 3rd largest in the private pharmaceutical market in South Africa (IQVIA MAT August’22), and is among the most distributed generic players in the United States For more than eight decades, making a difference for patients has inspired every aspect of Cipla’s work. Our breakthrough offering of triple antiretroviral therapy for HIV/AIDS for less than a dollar a day in Africa in 2001 is widely recognized as having helped put inclusiveness, accessibility and affordability at the center of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to health in pursuit of its goal of “Caring for Life” and deep-rooted community ties wherever it operates make it a partner of choice for global health organizations, peers and all stakeholders. For more information, visit www.cipla.com or click on TwitterFacebook, LinkedIn.