News | May 22, 2022
Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
A total of five observations for Goa and 17 for Monroe
A total of five observations for Goa and 17 for Monroe
According to IQVIA sales data for the 12-month period ending March 2022, the Zytiga tablets, 500 mg market achieved annual sales of approximately US $ 260.2 million
Purpose-built bioconjugation facility in Lonza’s Ibex Dedicate Biopark in Visp, Switzerland to support the potential commercial launch of Kodiak's lead product candidate KSI-301 for high-prevalence retinal diseases
ASC22 (Envafolimab) is a subcutaneously administered single-domain antibody against PD-L1 and has the potential to restore virus-specific immune responses in patients with chronic viral infection
Glenmark's current portfolio consists of 174 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the USFDA
While Pregabalin will be manufactured at the Aurangabad facility, Iloperidone will be manufactured at the Goa facility
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
Erytech is evaluating valuable strategic options to leverage its Erycaps platform and its development and manufacturing capabilities with complementary assets and/or a broader corporate transaction
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
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