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Custom Synthesis & Manufacturing

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Agno Pharma is a US-FDA approved CRO/CMO, with a US-FDA approved and inspected ISO 9001, ISO 14001, & OHSAS 18001 Certified GMP API Facility in China. For the last ten years, Agno Pharma has been providing outstanding custom synthesis and manufacturing services. The majority of our clients are located in the US, Europe, Japan and Singapore. Our projects range from early phase development to commercialization, both cGMP and non-GMP. As drug discovery projects from our clients progress towards late-stage lead optimization, members of our scale-up team are deployed within the project teams to engage in early process chemistry research and development support. This enables seamless process transfer to our manufacturing team, where drug product intermediates or API is manufactured in our wholly-owned manufacturing facility. All of our custom synthesis and manufacturing services are conducted under conditions of strict confidentiality. Our integrated project teams are supported by a highly experienced and dedicated group of scale-up chemists. Working with reactors with a temperature range from -100˚C up to 300˚C, and scales ranging from 50 L to 5000L, value is delivered to customers by efficient in-house synthesis of key project intermediates (up to metric ton quantities) and active pharmaceutical ingredients. Manufacturing is performed in our wholly-owned manufacturing facility (managed under ICH cGMP for all products) or at JV sites (with client's permission and preference)
Custom Synthesis & Manufacturing Custom Synthesis & Manufacturing Custom Synthesis & Manufacturing

 

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Custom Synthesis & Manufacturing
Chemical Process Development
API Section of IND
High Potency APIs
Medicinal Chemistry FTE
Analytical Development & Validation
ICH Stability Storage & Testing
Sourcing, Logistics & Testing