Drug Approval | November 19, 2024
Shilpa Pharma Lifesciences received CEP from EDQM for API, Octreotide
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis
Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
This is used to treat central diabetes insipidus and bedwetting
Critical resources will help Genvor to grow and scale biological crop protection products and innovative trait technologies
Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration
GL0034 administered once-weekly confirmed clinically meaningful weight loss and improved glucometabolic parameters over a 4-week treatment period in individuals with obesity
Zealand Pharma anticipates initiation of a Phase 2b clinical trial in H2 2024
This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals
Establishing Asymchem’s first manufacturing footprint in Europe
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