CMC: Rondaxe API Manufacturing Cost Estimates & Cost of Goods Analysis

Overview

Rondaxe industry professionals and our proprietary software system will produce API manufacturing cost estimates based on routes of synthesis.  Our analysis includes a literature search, patent inquiry, analysis of synthetic route and yields, starting material analysis, manufacturing facility and/or specialized processing requirements, labor requirements etc. Based on this information, we will prepare a manufacturing cost estimate on request. This estimate will include information on selected route, expected yields, route challenges, manufacturing and safety concerns, starting material cost and a discussion on the anticipated cost of the API/intermediate.

Services

We provide three levels of services for cost analysis:

• Cost estimate of API for a single synthetic route with basic background information and discussion of the basis of the estimate
• Cost estimate of API with a discussion of synthetic route, consideration of alternative routes, including background information and discussion of the basis of the estimate with supporting tables and graphs
• Cost estimate of API with a detailed discussion of the estimate, possibly slides for a presentation, and research
• into specific issues: Requires an in-depth discussion with client to understand the deliverables

Benefits

• Understand the challenges of selected synthetic routes
• Analysis of manufacturing and equipment requirements
• Starting material cost and sourcing challenges
• Analyze material costs versus manufacturing costs
• Estimates of manufacturing cost at different geographical location
• Guidance on most cost effective synthetic route for desired production volume
• Direct development efforts appropriately to drive down overall cost
• Understanding of overall API cost

Clients

• Established Pharmaceutical Companies
• Emerging Pharmaceutical & Biotech Companies
• API Sourcing Professionals
• Generic API Manufacturers