Joining this discussion late.
Did some basic digging - companies that have filed DMFs for Lactulose API from FDA site
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/UCM370722.xls
- Am intrigued by the fact that Bulk manufacture of Lactulose is limited to 7-8 companies effectively worldwide, but unable to fathom why?
- Lactose India has not filed for Lactulose DMFs so far - why? although company mentions - the plant will produce Lactulose Concentrate and Lactulose Solution USP / EP in Commercial Drum packs of 280 Kgs. Is the game plan only to supply to semi-regulated markets?
- It appears there are extensive cross-linkages between Lactose and bulk Lactulose suppliers. That may be a good to establish - in a bid to establish Market size
Hoping some of you will be inspired to take the digging further