NewRoute Pharma, established in 2012, specializes in the R&D, production, and sales of APIs and pharmaceutical intermediates. The company focuses on the technological development and commercialization of novel drugs, offering a full-industry-chain service platform to provide comprehensive support in new drug development, production, and related services for pharmaceutical enterprises.
APIs Development & Registration Services
· Synthesis route development & optimization
· Pilot transfer and process scale-up
· Process verification method development
· Stability testing
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Analytical Method Development
· Elemental Impurity Research and Testing
· Residual Solvent Research and Testing
· Impurity Research and Testing
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Impurities & Working Standards
Customization Services
· Chiral impurities
· Impurities for registration use
· New drug impurities
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Formulation Development
· Reference formulation analysis
· Stability testing
· Documentation preparation and submission
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