Broker's Call: Zydus Wellness (Buy)
ICICI Securities04-04-2022
ZyCoV-D found to be efficacious, safe' in phase-III trials
Clinical trial outcomes of the Zydus' vaccine have been peer-reviewed and published in The LancetZYDUS WELLNESS LTD.-$ - 531335 - Compliances-Reg. 39 (3) - Details of Loss of Certificate / Duplicate Certificate
Intimation of Loss of Share Certificate.ZYDUS WELLNESS LTD.-$ - 531335 - Closure of Trading Window
Intimation of closure of Trading Window.Zydus gets US regulator's PAS for generic version of Mycophenolate Mofetil for injection
The Prior Approval Supplement (PAS) granted by the US Food Drug Administration (USFDA) is for Mycophenolate Mofetil for injection of strength 500 mg/vial, the generic equivalent of CellCept injection, the company said in a regulatory filing.Zydus Lifesciences gets USFDA nod to market generic version of colestipol hydrochloride tablets
The approval by the US Food and Drug Administration is for colestipol hydrochloride of 1 mg strength, the company said in a regulatory filing.Zydus Lifesciences gets 3 observations from USFDA for Vadodara plant
Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility. The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022. The inspection closed with three observations, the drug firm said in a regulatory filing. "We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated. As per the US health regulator, an FDA Form 483 (observation) is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act.Zydus to launch anemia oral treatment for chronic kidney disease patients
CKD is a serious progressive medical condition characterised by a gradual loss of kidney function, usually accompanied by other comorbidities including anemia, cardiovascular diseases such as hypertension, heart failure and stroke, diabetes mellitus, eventually leading to kidney failureZYDUS WELLNESS LTD.-$ - 531335 - Announcement under Regulation 30 (LODR)-Code of Conduct under SEBI (PIT) Regulations, 2015
Intimation under Regulation 7(2) of SEBI (PIT) Regulations, 2015Zydus gets regulator nod to market generic diabetes drug in American
Zydus Group on Wednesday said it has received final approval from the US health regulator to market diabetes medication Dapagliflozin tablets in the American market. The drug maker has received final approval from the US Food and Drug Administration (USFDA) to market the drug in the strengths of 5 mg and 10 mg. Dapagliflozin is used with a proper diet and exercise programme to control high blood sugar in people with type 2 diabetes. The drug also lowers the risk of heart failure in adults with type 2 diabetes with heart disease. It is also used to lower the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalisation for heart failure in adults with chronic kidney disease. Dapagliflozin works by increasing the removal of sugar by kidneys. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Group stated. The group now has 328 approvals and has so far fi