Tablets & Capsules

TC0916

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54 September 2016 Tablets & Capsules of domestically produced excipients, national distributors minimize lead times because they can usually ship from several distribution centers, whereas manufacturers usually only ship from one or two. Regional distrib- utors, as you'd expect, hold their stock in the region they serve, so they too usually offer quicker shipment. Lower shipping costs. Excipient distributors that offer several excipients can save FDF manufacturers freight costs by combining those excipients into a single shipment. Technical service expertise and responsiveness. It might be counterin- tuitive to think that a distributor can offer better technical service than the excipient manufacturer, but that's true in some cases. That because most excipient manufacturers spend a lot of their technical service time and efforts supporting their larger-volume mar- kets, such as cosmetics and food. Excipient distributors, especially those that have a long history representing a particular product or group of prod- ucts, often have the experience and knowledge to quickly address techni- cal service and documentation issues raised by of FDF manufacturers. In addition, distributors that offer a num- ber of excipient types can often rec- ommend products or grades that work well together in formulations. Other services that excipient dis- tributors can offer FDF manufacturers, include sourcing, inventory services, repackaging, dilution, further process- ing, and sampling. Sourcing. This involves locating and vetting an excipient for a cus- tomer. This is especially valuable if there's no readily available source of a compendial excipient. Vendor-managed inventory. In this situation, the FDF manufacturer pro- vides usage/demand information to the excipient distributor, who then takes responsibility for maintaining an agreed amount of inventory of that excipient at the FDF manufacturer's facility. Repackaging. Many distributors receive excipients from manufacturers in bulk. If there is an "authorized" rela- tionship between the manufacturer and distributor, the distributor may repackage (under excipient GMPs and with the permission and endorsement of the manufacturer) the bulk ship- ments into containers that are more manageable for the FDF manufacturer, such as bags, drums, pails, and bottles. Some distributors will also repackage (again, under GMPs) the excipients into customer-specified containers and/or to specific volumes. Any dis- tributor that repackages an excipi- ent—with or without the manufac- turer's permission/authorization and at the request of an FDF manufacturer— should take full responsibility for fol- lowing the appropriate GMPs and allow its process to be audited by FDF customers. Dilution. At the manufacturer's request, some distributors may change the concentration of an excipient by diluting it before repackaging and dis-

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