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[RegAffairs]Excipient clarity
Dear forum An injectable lyophilized product under development which is planned for EU & US submission. sucrose is one of the ingredient. US & EU pack insert mentions about 2 mg difference. This quantity is after reconstitution. Require help whether can we harmonise uniform quantity for both the geographies. advance thanks Prasanna sagar -------------------------------------------- prasanna sagar prasannasagar@rediff.com -------------------------------------------- |
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