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eye on Drawing on many years of experi- ence, here are my thoughts on the key areas where excipient distribu- tors can add value to pharmaceutical manufacturing. Quality starts at the source The pharma niche was an obvious choice for us, and the next step was identifying quality-oriented suppliers with a long-term interest in establish- ing and maintaining a strong pres- ence in pharma. In the early 1990s, most ingredient manufacturers were new to pharma and the term "excipi- ent" was almost a foreign word. At the time, most food-ingredient man- ufacturers had a small pharma divi- sion—just one or two employees— that constantly had to justify its existence to management. It seemed like a lot of work and a big hassle to move such small volumes. Those small divisions, however, generated very high profit margins, and gradu- ally, they started moving toward cen- ter stage. The word "excipient" wasn't so foreign anymore. Eventually, we had more than 25 suppliers in our portfolio, each one a world-class excipient manufacturer. We call the portfolio our tool box: It comprises different excipient manu- facturers that enable our customers to find whatever material they need to address drug product functionality and efficacy, from R&D to large-scale production. Pharma manufacturers— our customers—welcome a distribu- tor who offers multiple excipients to suit all delivery platforms. This was the first key to our success: choosing suppliers with innovative products who are driven by quality, quick to respond, and flexible. Global connectivity The world is forever becoming smaller, and pharma manufacturers operate multiple sites around the globe to serve different markets. That makes consistency in excipient sourcing, sup- pliers, transparency, and supply-chain security imperative. Yet even today, distribution channels are fragmented and there are too many missing links— even black holes—in supply-chain traceability. This can jeopardize excipi- ent integrity and patient safety, and it explains why pharma manufacturers and excipient suppliers put a high value on working with a distribution partner who can serve their key pharma mar- kets. Product knowledge, technical support, quality service, and sound logistics are what build global supply- chain confidence. For those reasons, Mutchler agreed to be acquired in 2016 by IMCD Group's pharma busi- ness unit, which has launched our company from its base in the USA and Puerto Rico into the global market. Quality compliance Successful excipient distributors should physically mirror the pharma manufacturers they supply. That is, their facilities should look like their customers' sites or even better. That includes warehouses and repacking operations that meet GMP require- ments; robust procedures that keep pests under control; and inventory that is well managed. It also requires top-notch incoming/shipping, train- ing, waste disposal, carrier/key- Tablets & Capsules April 2017 45 Dwight Mutchler Mutchler Pharmaceutical Ingredients excipients In this edition of the column, Dwight Mutchler discusses how excipient distrib- utors have evolved to help pharmaceutical manufacturers and excipient suppliers do their job more easily, effectively, and economically. The pharmaceutical industry is as strict they come in demanding quality products and procedures. And right- fully so, because that never-satisfied outlook helps ensure confidence in the efficacy and safety of pharmaceuticals. Because of the "high-maintenance" nature of pharmaceutical manufactur- ers, many companies that distribute pharma ingredients have shifted their focus to markets whose customers are less demanding and/or address only the basic supply obligations of the pharma sector. My company, however, took the opposite approach. In 1993 we opted to focus exclusively on the pharma industry and changed our name to reflect that. It wasn't a tough call. As a small distributor, we realized that the most promising path to success was to work "where the trees are thin." That is, we stayed away from market seg- ments where the large generalist chemical distributors worked in favor of serving pharma, where relatively few distributors were dedicated to replicating the industry's obsession with quality. Pharma customers and specialty suppliers were both eager for supply-chain partners who under- stood the industry and could navigate through a thicket of regulations to supply pristine raw materials and sup- ply them on demand.