API and Raw Material

API / Raw Material Supply Network and Contract Manufacturing Challenges

Active pharmaceutical ingredients (API), excipients and other raw material suppliers serve a very demanding and diverse type of customers including pharmaceutical / biopharma companies and their contract manufacturing and packaging partners. As the pace of change in the global pharmaceutical market increases due to globalization, patent expiration, consumer diversity and counterfeiting threats, etc., the upstream API and raw material suppliers must be ready to react quickly to customer need or risk lost business and profitability.

How TraceLink can help API, Raw Material and Component Suppliers

• Reducing operational costs.  Slowing top-line growth, increased material costs and growing regulatory overhead all serve to pressure profit margins. In response, you need to reduce operating overhead, reduce on-hand inventory, and reduce the cash-to-cash cycle time.
• TraceLink’s Predictable Supply Suite can help by reducing process delays, eliminating manual work steps and improving accuracy at all points in the production lifecycle. Automate data collection and analysis, lean inventory levels by leveraging accurate supply inventory data and optimize production planning with enhanced metrics on outsourced manufacturing, contract partner and supplier performance.  

• Gaining a competitive advantage. Competition is fierce, particularly from API and excipient suppliers in the “pharmerging” markets of China and India. Yet, pharmaceutical companies, OTC firms and CMOs are looking today for more than just low price. They want to reduce the risk to finished goods product quality and missed customer schedules. Your customers also want improved operational flexibility by working with a supplier who can deliver existing or new product when and where needed even without large lead times. In response, you need to differentiate yourselves through best-in-class customer service and ease-of-doing-business without massive infrastructure investment.
• TraceLink’s Predictable Supply Suite can help by getting you connected to your customers in real-time, improving your insight into customer needs and enhancing the knowledge you need to provide better quality, timeliness and performance than your competitor. Speed negotiation of new material deliveries, respond quickly to customer requests for schedule updates and leverage greater insight into customer forecasts to help optimize your facility setup.

• Managing outsourced product and channel complexity. You already serve numerous brand companies and their CMO/CPO partners, each with their own supply needs and preferred ways of doing business. Using traditional phone, FAX and email communication methods to meet the myriad of specific business process, technical integration, and scheduling requirements you face can swamp your operations. In response, you need a flexible connection and collaboration platform that will scale to your business needs without large up-front investment.
• TraceLink’s Predictable Supply Suite can help by providing a flexible manufacturing and supply collaboration environment that gets your virtual teams sharing information and insight with Tier-1 and long-tail contract partners and customers. Quickly create secure business Clouds that connects the people, business processes and information that you need on a per-partner, per-product or per-project basis. Without massive overhead and technical complexity, get team members sharing production status, quality documents, inventory information, notes, discussions and other contextual information in whatever form they need when they need it. 

• Ensuring product trust. API and other ingredient supplies have gotten plenty of media attention recent years for all the wrong reasons. Numerous articles have covered bad Chinese material supplies used for Heparin production, diethylene glycol used in place of glycerin syrup and other toxic substitutions. With the result of thousands of deaths worldwide on a yearly basis from these issues, questions are being asked about the safety of raw material suppliers and new regulations are being proposed. In response, you need to be ready to demonstrate that your products are safe by providing detailed quality and supply chain traceability documentation to customers and regulatory bodies when and where required
• TraceLink’s Predictable Supply Suite can help by providing unique product identity and end-to-end chain of custody as they travel through the distribution, agent, broker and contract manufacturing and customer channels. Create package-level and case-level identity. Enable product authentication, both in bulk and per-package, throughout the channel. Support fast recall of product through proactive notification to channel partners of adverse events. Securely share quality documentation and artifacts with customers.

Next steps

• Try It Yourself.  In minutes, launch a no obligation FREE TRIAL of our Predictable Supply Suite. Create your own Process Link collaborative team workspace, invite and quickly connect to virtual team members, then experience a new world of production visibility and tracking across your contract manufacturing operations!
• Demo Production Tracking.  Request a guided PERSONAL DEMO of our Production Tracking and ProcessLink solutions. On your schedule, one of our team members will take you through our solution.

Explore More

• Discover Production Tracking.  Find out how the TraceLink Production Tracking solution can give you visibility and control throughout the entire contract manufacturing lifecycle. Go Production Tracking
• Experience ProcessLink.  Review TraceLink's innovative approach to connecting you and your internal contract manufacturing teams to your partners both fast and flexibly. Go ProcessLink