Description
Renejix Pharma Solutions is a leading Contract Development and Manufacturing Organisation (CDMO) focused on small molecule oral dosage forms. With over 200 finished dosage forms (FDFs) produced and more than 5 billion dosages annually, the company boasts a dedicated workforce of approximately 500 employees. Renejix facilitates the journey of molecules from concept to commercialization, significantly reducing timelines by up to 20 weeks in both early and late phase development. The company develops and manufactures a wide array of non-sterile dosage forms across preclinical, clinical, and commercial scales, including tablets, minitablets, capsules, softgels, solutions, suspensions, powders, granules, topicals, semisolids, creams, transdermal patches, and oral films. Their capabilities encompass both standard technologies, such as controlled release, and advanced lipid-nanotechnology drug delivery systems, with the capacity to handle potent molecules and controlled substances.
Services include:
- 505(b)(2)
- Accelerated Stability Studies
- ADMET
- Analytical Services
- API Solubilization Technologies
- Assay Development
- Bioanalytical Services
- Bioavailability Studies
- Biostatistics
- Blending
- Lab Services
- cGMP Synthesis
- Chemical Analysis
- Raw Materials
- Chemistry (CMC)
- Medicinal
- Chiral Separations
- R&D
- Chromatography
- CIP Process Systems
- Clinical Supply Management
- Clinical Trials Management
- Clinical Trials
- Manufacturing
- Coating & Lamination
- Sourcing
- Comparator Drug Purchasing
- Consulting
- Regulatory
- Contract Development and Manufacturing (CDMO)
- Contract Manufacturing (CMO)
- Contract Packaging
- Contract Research (CRO)
- Dissolution Testing
- Distribution
- Documentation Support Services
- Dosage Form Development
- Drug Delivery Devices
- Drug Design
- Drug Development
- Contract Development
- Drug Screening
- Electronic Data Management
- Encapsulation
- Environmental Analysis
- Environmental Monitoring
- Fluid Bed Processing
- Forced Degradation Studies
- Process Development
- Formulation Development
- Controlled Release
- Granulation
- Hot Melt Extrusion
- In Vitro Testing
- Testing
- IND/NDA Submissions
- Lot Release Testing
- APIs (Active Pharmaceutical Ingredients)
- High Potency
- Bioequivalence
- Capsule
- Clinical Trial Materials
- Controlled Substances
- Dose Form
- Non-Sterile
- Gels
- Generics
- Liquids
- Nutraceuticals
- Oral Drug Delivery
- Orally Dispersible Tablet
- OTC
- Powders
- Semisolids
- Soft Gels
- Solid Dosage
- Solutions & Suspensions
- Sustained Release
- Tablets
- Mass Spectrometry
- Materials Analysis
- Measuring & Testing Technology
- Micro FT-IR Analysis
- Microbiological Testing
- Microencapsulation
- Micronization
- Mixing & Blending
- Nonclinical Research
- Packaging
- Blister
- Certification
- Closures
- Design & Testing
- Labelling
- Plastic Bottles and Jars
- Particle Characterization
- Particle Size Analysis
- Particle Size Classification
- Pharmacovigilance
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Preclinical Study Design
- Preclinical Testing
- Preclinical Testing Formulations
- Preformulation
- Process Analytical Technology (PAT)
- Process Characterization
- Process R&D
- Process Validation Studies
- Project Management
- Quality QA/QC
- R&D Services
- Raw Materials Analysis
- Scale-Up
- Spray Drying
- Stability Studies
- Stability
- ICH
- Storage
- Secondary Packaging Materials
- Supply Chain Management
- Tablet Coating
- Technology Transfer
- Thermogravimetric Analysis
- UV-VIS Spectrophotometer Analysis
- Validation
- Clinical
- Warehousing
- X-Ray Crystallography
- X-Ray Fluorescence
- X-Ray Powder Diffraction
- X-Ray Spectroscopy
- Finished Dosage Forms
Renejix Pharma Solutions stands out as a pivotal partner in the pharmaceutical industry, committed to delivering high-quality and efficient drug development solutions. For more information, please visit renejix.com.
Capabilities
- Accelerated Stability Studies
- ADMET
- Analytical Services
- API Solubilization Technologies
- APIs (Active Pharmaceutical Ingredients)
- Assay Development
- Bioanalytical Services
- Bioavailability Studies
- Bioequivalence
- Biostatistics
- Blending
- Blister
- Capsule
- Certification
- cGMP Synthesis
- Chemical Analysis
- Chemistry (CMC)
- Chiral Separations
- Chromatography
- CIP Process Systems
- Clinical
- Clinical Trial Materials
- Clinical Trials
- Closures
- Coating & Lamination
- Comparator Drugs
- Consulting
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Contract Research (CRO)
- Controlled Release
- Controlled Substances
- Design & Testing
- Dissolution Testing
- Documentation Support Services
- Dosage Form Development
- Dose Form
- Drug Delivery Devices
- Drug Development
- Drug Screening
- Electronic Data Management
- Encapsulation
- Environmental Analysis
- Environmental Monitoring
- Finished Dosage Forms
- Fluid Bed Processing
- Forced Degradation Studies
- Formulation Development
- Gels
- Generics
- Granulation
- High Potency
- Hot Melt Extrusion
- ICH
- In Vitro Testing
- IND/NDA Submissions
- Lab Services
- Labelling
- Liquids
- Lot Release Testing
- Mass Spectrometry
- Materials Analysis
- Measuring & Testing Technology
- Medicinal
- Micro FT-IR Analysis
- Microbiological Testing
- Microencapsulation
- Micronization
- Mixing & Blending
- Non Sterile Dosage
- Nonclinical Research
- Nutraceuticals
- Oral Drug Delivery
- OTC
- Packaging
- Particle Size Analysis
- Pharmacovigilance
- Photostability
- Physical Testing
- Pilot-Scale Filling
- Plastic Bottles and Jars
- Powders
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Analytical Technology (PAT)
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Quality QA/QC
- Raw Materials
- Raw Materials Analysis
- Regulatory Services
- Research & Development
- Scale-Up
- Secondary Packaging Materials
- Semisolids
- Soft Gels
- Solid Dosage
- Solutions & Suspensions
- Sourcing
- Spray Drying
- Stability Studies
- Storage
- Supply Chain & Logistics
- Supply Chain Management
- Sustained Release
- Tablet Coating
- Tablets
- Technology Transfer
- Testing
- Thermogravimetric Analysis
- UV-VIS Spectrophotometer Analysis
- Validation
- Warehousing
- X-Ray Crystallography
- X-Ray Fluorescence
- X-Ray Powder Diffraction
- X-Ray Spectroscopy
Contact Information
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