Cipla Limited (“Cipla”), today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Testosterone Cypionate Injection 100mg/ml and 200mg/ml from the United States Food and Drug Administration (US FDA). Cipla’s Testosterone Cypionate Injection 100mg/ml and 200mg/ml is AO-rated generic therapeutic equivalent version of Pharmacia and Upjohn’s DepoTestosterone®. It is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone. According to IQVIA (IMS Health), Depo-Testosterone® and its generic equivalents had US sales of approximately $191M for the 12-month period ending April 2018. The product is available for shipping immediately.
Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 80 countries. Our portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.
Whilst delivering a long-term sustainable business, Cipla recognises its duty to provide affordable medicines. Cipla’s emphasis on access for patients was recognised globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and thereby treating many millions of patients since 2001. Cipla’s research and development focuses on developing innovative products and drug delivery systems.