Alembic Pharmaceuticals receives USFDA approvals for 5 products in Q1FY24
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
Intent to start at least 5 innovative Phase 3 vaccine programs by 2025
Decisions on the marketing authorization for Rystiggo in the European and Japanese markets are expected in Q1 of 2024
Survodutide has a novel mechanism of action (agonism of the dual GCG/GLP-1 receptors) that may have direct effects on energy expenditure in the liver in addition to decreasing appetite
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
GL0034 is a novel, investigational glucagon-like peptide 1 receptor agonist (GLP-1RA) being studied for the treatment of type 2 diabetes and obesity
The company will submit its comprehensive response on these observations to the USFDA
The company expects to capture a 10 per cent share in Spain’s $6.34 million meropenem market and consolidate its position in other European countries
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