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Tedor Pharma Inc.
Tedor Pharma Inc. offers pharmaceutical product development through commercialization services for your IND, NDA or ANDA needs. The Company is comprised of a highly qualified and experienced team of scientists, production specialists and business development personnel with over 50 years of expertise in pharmaceutical product development.
Company Contact:John Yanusas
Phone:401 658 5219
Fax:401 658 5263
Email:jyanusas@tedor.com
Website:http://www.tedor.com
Address:400 Highland Corporate DriveCumberland, RI 02864 USA
Equipment List in PDF:download
  • USA
ANALYTICAL
API Type
Controlled SubstanceNutraceuticalPolymerSmall Molecule
Sample Type
APICleaning/ValidationContainer/ClosureDosage formRaw Material
Service Type
DeformulationDifferential Scanning CalorimetryMethodsMethod DevelopmentMethod TransferMethod ValidationTests - Dissolution/DisintegrationDisintegrationDissolution App. I/IITests - Impurities/DegradationForced DegradationImp./Deg QuantitationTests - PhysicalParticle SizePhysical TestingTablet Hardness/FriabilityTests - StabilityAccelerated StabilityICH/Commercial Stability TestingPhotostabilityStability Storage (I/II)Stability Testing (I/II)Tests/Analysis - OtherAssay/PotencyComparator AnalysisCompendial TestingContent UniformityExtractables/LeachablesMoistureResidual Solvent AnalysisSample AnalysisThermal Analyses/DSCTrace AnalysisTets - ReleaseIn-vitro release testingLot and Batch Release TestingWet Chemistry
API/BIOLOGICS/REAGENTS
API Development Stage
DiscoveryGMP clinicalGMP commercialPreclinical
CONSULTANT
Formulation Categories-Consultant
Combination ProductsControlled SubstancesGenericsNutraceuticalsOral/Buccal/SublingualChewablesEffervescentODT/Fast MeltOral MR TabletOral SolidOTC formulationsTaste Masking
FACILITY REGULATORY STATUS
Facility regulatory bodies
DEAFDA
Facility subcategories
InspectedLicensed/registered
FORMULATION/MANUFACTURING
API/Business Sector Types
Controlled SubstanceGeneric SectorNutraceuticalSmall Molecule
Development Stage
FormulationFormulation DevelopmentManufacturingGMP Clinical (Phase I/II)GMP CommercialICH BatchesScale upValidation BatchesProcess Development
Formulation Type
API in BottleGenericsInhalationOralEncapsulationMicroencapsulationParticle Engineering
MICROBIOLOGICAL TESTING
Formulations Serviced
InhalationOralOTC formulations
PACKAGING/FILLING/LABELING
Development Stage
ClinicalCommercial mfg
Packaging Filling Services
Child-ResistantControlled Substance PackagingFilling Services
PREFORMULATION
Preformulation Services
Accelerated StabilityBCS ClassificationBulk and Tap DensityExcipient CompatibilityForced Degradation StudiesHydrates and SolvatesHygroscopicityIntrinsic DissolutionMelting PointMicroscopyMoisture ContentOsmolarityParticle size measurements Partition CoefficientpH-Rate profilesPhysical PropertiesPkaPolymorphPowder FlowabilityPowder Surface CharacterizationRheology/ViscositySalt FormationSEM MicroscopySolid State CharacterizationSolubilitySpecific GravityThermal Analyses/DSCWater Sorption and Desorption StuiesZeta Potential
REGULATORY
Formulation Category
Combination ProductsControlled SubstancesDPIGenericsInhalationNutraceuticalOralOTC formulations
Regulatory Services
ANDACMCNDAPost approval services
SUPPLY CHAIN MANAGEMENT
Supply Chain Services
Import/ExportSupply Chain Management
Analytical Development
General Properties
Size of the Facilities (square feet) 40
Number of People 25
Equipment
EquipmentCheck if exist
HPLC
LC-MS
GC
NMR
Solid State NMR
DSC
TGA
FTIR
NIR
Raman
UV-Vis
PXRD
Particle Sizer
Karl Fischer
HPLC Stability Indicating Methods Developed for Oral formulations (last 3 years)
Activity/PhaseOral TabletOral LiquidOral Softgel CapsuleOral Hard Gel CapsuleODT
Preclinical1
Phase I – II
Phase III –commercial821

Oral Formulations
General Properties
Organic Solvent Handling Capabilities
Milling Equipment
Equipment TypeLab ScalePilot ScaleProduction
Fluid Energy Mill
Hammer Mill12
Conical Screen Mill1
Oscillating Granulator1
Ball Mill
Other
Mixers/Blenders
Mixer TypeLab ScalePilot ScaleProduction
Hi Speed - Barrel
Hi Speed - Bowl
Fluid bed22
Low Speed - Planetary21
Low Speed - Barrel
V-Shaped105
Double-Cone
Cubical
Ribbon
Sigma-Blade
Other
Granulators
TypeLab ScalePilot ScaleProduction
Low- Shear Granulator1
Hi- Shear Granulator23
Fluid bed22
Roller Compactor1
Other
General Extruder11
Melt Extruder
Drying Equipment
Equipment TypeLab ScalePilot ScaleProduction
Fluid-Bed22
Tray21
Vacuum
Microwave
Other
Tabletting
Equipment TypeLab ScalePilot ScaleProduction Scale
Compaction Simulators
Single-Station2
Rotary-Single Layer3
Rotary-Bilayer
Rotary-Trilayer1
Rotary-Dry Coater
Other
Encapsulation
Equipment Type1X10X100X
Hard Gelation Manual6
Hard Gelation Semi-automatic
Hard Gelation Automatic3
Softgel
Hard gel/liquid

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