The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
Lonza Bend (US) upgrades capabilities in early phase clinical manufacturing services with the addition of bottling and labeling equipment
To co-develop and co-commercialize MK-6070, an investigational delta-like ligand 3 (DLL3) targeting T-cell engager, worldwide except for Japan where Merck retains exclusive rights
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
Revolutionary technology will further boost OneSource’s scientific services offerings
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept
Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia
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