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FDA - GMP

PolyCrystalLine SpA has been inspected by FDA and received the GMP certification from AIFA for the physico-chemical analyses. For any request please contact us soon.

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MyCrystalPro: Our Online Portal

From our experience a shared over-view is what enables effective communication within a group. In order to offer an added value to our clients at Polycrystalline we developed our own web portal for project communication named MyCrystalPro. MyCrystalPro stands for “My Crystalline Project”, because at Polycrystalline we offer a transparent and streamlined partnership, with joint responsibilities and interactions. In our unique interface there are four major features that summarize our governance: E

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MyCrystalPro: Our Online Portal

From our experience a shared over-view is what enables effective communication within a group. In order to offer an added value to our clients at Polycrystalline we developed our own web portal for project communication named MyCrystalPro. MyCrystalPro stands for “My Crystalline Project”, because at Polycrystalline we offer a transparent and streamlined partnership, with joint responsibilities and interactions. In our unique interface there are four major features that summarize our governance: E

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Des-Methyl-Venlafaxine Salt

  New Crystalline Forms of Des-Methyl-Venlafaxine Salt Discovered PolyCrystalLine s.r.l. and Segrub Pharmaceuticals have developed a generic equivalent to Pristiq (desvenlafaxine succinate). This DEP001 product is expected to enter the US market at least three years before any other generic desvenlafaxine products enter the market. Pristiq sales are projected to exceed one billion dollars yearly. Pristiq was approved in 2008 by Wyeth Pharmaceuticals for the treatment of major depres

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Polymorphs of Dex-Lansoprazole

  New Crystalline Forms of Dex-Lansoprazole Discovered PolyCrystalLine s.r.l. and Segrub Pharmaceuticals have developed a generic equivalent to Kapidex (dexlansoprazole). This DEP002 product contains a new and stable crystal of dexlansoprazole which circumvents Takeda’s intellectual property. Kapidex is a proton pump inhibitor that obtained FDA approval in 2009 by Takeda Pharmaceuticals for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GE

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CF@BO 2019, June 9 - 11

ABOUT THE CONVENTION The investigation and optimization of crystal forms are at the forefront of industrial as well as fundamental research. The event will bring together academic and industrial experts interested in sharing experience and discussing perspectives and new challenges regarding: Recent advances in solid forms discovery Synthesis and properties of crystal forms Multicomponent crystal forms Intellectual property issues WHY ATTEND? The convention will address not only issues at the frontier

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