Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Coverage of CGHS cities has expanded from 25 cities in 2014 to 80 in 2023
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The new API plant is set up to meet all domestic and international regulatory standards and will manufacture niche molecules that have a global requirement
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
Acquisition accelerates Cosette’s women’s health portfolio; with a differentiated, commercial stage, patent protected product
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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