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This is about designing for global scalability, compliance, and biologics maturity." Hari Kiran Chereddi, MD & CEO, HRV Pharma and NHG Pharma Strategic Implementation Framework Successfully capitalizing on the GLP-1 opportunity requires comprehensive strategic pillars: Early-stage DMFs: Developing Drug Master Files for GLP-1 analogues ahead of patent expiry CDMO Infrastructure: GLP-1 focused Contract Development and Manufacturing Organization investments for regulated markets Regulatory Collaboration: Establishing collaborative pathways with global regulatory authorities Advanced Manufacturing Platforms: Sophisticated peptide synthesis capabilities AI-Integrated Quality Systems: Advanced Quality Control and Quality Assurance processes for biologics India's Competitive Positioning in Biologics India currently contributes over 20% of global generic medicines , with established expertise in chemistry-led drug development

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Sci Transl Med 2024;16:eadp5765

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