Cipla receives final approval for generic version of Pfizer’s Depo-Provera®
- Post By : Kumar Jeetendra
- Source: CIPLA
- Date: 28 January, 2019
Mumbai, India, January 28, 2019: Cipla Limited (BSE: 500087; NSE: CIPLA EQ; and hereafter referred to as “Cipla”) today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Medroxyprogesterone Injectable, 150mg/mL from the United States Food and Drug Administration (US FDA).
Cipla’s Medroxyprogesterone Injectable, 150mg/mL is AB-rated generic therapeutic equivalent version of Pfizer’s Depo-Provera®. It is a progestin indicated only for the prevention of pregnancy. According to IQVIA (IMS Health), Depo-Provera® and its generic equivalents had US sales of approximately $159M for the 12-month period ending November 2018.
Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets.
Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets.
Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Sept’18), 3rd largest in the pharma private market in South Africa (IQVIA YTD Aug’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work.
Our paradigm-changing offer of a triple anti-retroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement.
A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of ‘Caring for Life’ and deep-rooted community links wherever it is present make it a partner of choice to global health bodies, peers and all stakeholders.
For queries, please contact:
Corporate Communications Investor Relations
Heena Kanal Naveen Bansal
E-Mail: CorpComm@cipla.com E-Mail: Investor.Relations@cipla.com