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3 MEGGLE | Co-processed lactose CombiLac ® BENEFITS – Direct compression – ODT formulations – Dry granulation CombiLac ® – Excellent compactibility – Excellent flowability – Fast, hardness-independent tablet disintegration for effective API release – Low friability – Overcomes individual ingredient compaction and handling limitations Application CombiLac ® is designed for DC and may be used in other formula- tion development approaches, such as dry granulation. In com- parison to a physical admixture of individual components, CombiLac ® provides enhanced compaction properties, as well as the flow performance necessary for increased production rates and decreased weight variation. If robust, time saving development of frequently used formulation ingredients is a top priority, ready- to-use CombiLac ® is the best choice. During production, reduced raw material testing is required due to its ternary combination. Regulatory & quality information The raw materials used to produce CombiLac ® , alpha-lactose monohydrate, MCC and native corn starch, comply with Ph.Eur., USP-NF and JP monograph requirements. Since no chemical modification results during co-processing and individual chemical identities are maintained, CombiLac ® can be considered as a physical blend of individual ingredients. Specifications and regulatory documents can be downloaded from www.meggle-pharma.com. Our pharma-dedicated production facility in Wasserburg, Germany is certified according to DIN ISO 9001:2008, has implemented cGMP according to the joint IPEC-PQG Good Manufacturing Practice Guide for Pharmaceutical Excipients and USP General Information Chapter <1078>. The Wasserburg facility demonstrates MEGGLE's complete lactose production capability range, including sieving, milling, agglomeration, spray-drying and co-processing. Additionally, MEGGLE is a member of IPEC (International Phar- maceutical Excipients Council). It has also implemented GDP according to the IPEC Good Distribution Practices Guide for Pharmaceutical Excipients. Both IPEC standards have been certified according to EXCiPACT ™ for manufacturing, testing, storage and distribution of lactose and co-processed excipients used as pharmaceutical excipients or claimed for pharmaceutical use. MEGGLE invests considerably in raw material resource sustain- ability, production standards, efficiency and is actively engaged in environmental protection. Excipients meeting pharmaceutical standards is our first priority.