Zydus Lifesciences announced that the USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara. The inspection was conducted from 15 April to 23 April 2024. The inspection closed with 10 observations. The Company will closely work with the USFDA to address and respond to the observations in an expeditious manner. Powered by Capital Market - Live News

Zydus Lifesciences announced that the New Drug Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA). CMS International Development and Management, a wholly-owned subsidiary of China Medical System Holdings (CMS) obtained an exclusive license for the product from Zydus in 2020.Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis. When kidneys are impaired as in patients suffering from Chronic Kidney Disease, EPO production is impaired, leading to development of anaemia. HIF-PHI promotes erythropoiesis through increasing endogenous erythropoietin, reducing hepcidin thereby improves iron availability.Discovered and developed by Zydus, Desidustat is being marketed by the group in India under the brand name Oxemia�. China Medical System Holdings through its wholly-owned subsidiary gained a royalty bearing, exclusive, sub-licensable license under the licensed technology and Zydus data to develop, register and to manufacture, use and commercialise the Product in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).Powered by Capital Market - Live News

Zydus Lifesciences announced the launch of Mirabegron Extended-Release Tablets, 25 mg in the US market. The company had earlier received final approval from the United States Food and Drug Administration (USFDA) to market Mirabegron Extended-Release Tablets USP 25 mg and 50 mg (USRLD: Myrbetriq� Extended-Release Tablets). Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently. Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group`s formulation manufacturing facility in Ahmedabad SEZ, India.Powered by Capital Market - Live News

Zydus Lifesciences announced that its wholly-owned subsidiary Sentynl Therapeutics, Inc. (Sentynl), has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for NULIBRY� (fosdenopterin) for Injection as the first therapy for the treatment of patients in Great Britain (GB) with Molybdenum Cofactor Deficiency (MoCD) Type A. This is an ultra-rare, life-threatening genetic disorder that often progresses rapidly in infants. It is known to impact fewer than 150 patients globally with a median survival age of four year. NULIBRY� is a first-in-class synthetic cPMP substrate replacement therapy that was approved by the U.S. Food and Drug Administration (FDA) in 2021 to reduce the risk of mortality in patients with MoCD Type A. Following this decision by the UK MHRA, NULIBRY� is the first and only approved therapy in GB for MoCD Type A.Powered by Capital Market - Live News

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) to market Letermovir tablets, 240 mg and 480 mg, (USRLD: Prevymis� tablets). Letermovir tablets are used to prevent disease caused by a virus called cytomegalovirus (CMV) in people who have received a bone marrow transplant or kidney transplant. The drug will be manufactured at the group`s formulation manufacturing facility at Ahmedabad SEZ, India. Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24). Powered by Capital Market - Live News