ORAL & SPECIALTY DRUG DELIVERY
The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The facility is the commercial manufacturing Center-of-Excellence for accelerated development programs and advanced oral dosage technology methods.
Small Molecule Analytical Services
The Central Islip facility is also a Center-of-Excellence for our Small Analytical Service. Our small molecule analytical team has over 30 years of experience providing broad-based and orthogonal analytical CMC services for stand-alone and integrated small molecule projects.
Clinical Supply Services
Our facility also offers comprehensive clinical packaging services including clinical supply management, package engineering, clinical manufacturing, primary and secondary packaging, global distribution and logistics, and return/destruction services. The facility features an isolated potent suite and DEA Schedule I-V controlled drug storage to handle even your most challenging products.
Size: 189,000 ft2
ADDRESS
400 S Technology Dr. Central Islip, NY 11722
PHONE
+1 631 210-5235
CAPABILITIES
- Analytical Development
- Analytical Methods Development
- Analytical & Micro Laboratory
- API Micronization
- Bioavailability Enhancement
- Blinding and Manufacturing
- cGMP Manufacturing
- Clinical Manufacturing & Blinding
- Package Engineering & Patient Kit Design
- Primary Packaging
- Oral Dose Packaging
- Secondary Packaging & Labeling
- Clinical Returns and Destruction
- Clinical Storage & Distribution
- Clinical Supply Management
- Cryogenic Milling
- Comparator Sourcing
- Complex Controlled Release
- Comprehensive Analytical Services
- Comprehensive Commercial Supply Solutions
- Controlled Release Development
- DEA Schedule I-V
- Early Phase Drug Development
- Fill/Finish
- Fluid Bed
- Granulation
- Formulation
- Formulation Development for Orals
- Global Comparator Sourcing
- Global Distribution
- Hard capsule filling
- Hot Melt Extrusion
- High Sheer Processing
- Manufacturing & Blinding
- Mechanical Milling
- Method Development
- Oral Manufacturing
- Orally Disintegrating Tablets
- Oral Formulation
- Particle Size Characterization
- Particle Size Engineering
- Process Development
- Project Management
- Quality Assurance & Quality Control
- Regulatory Support
- Release & Stability Testing
- Rx and OTC Softgel development and manufacturing
- Scale-Up and Product Launch
- Small Molecule Analytical Chemistry
- Softgel Technologies
- Solid State Screening
- Stability Studies
- Stability Testing & Storage
- Storage and Distribution
- Technology Transfers
Oral & Specialty Delivery
- Formulation
- Method Development
- Manufacturing & Blinding
- Release & Stability Testing
Small Molecule Analytical Chemistry
- Analytical Test Method Development and Validation
- Accelerated Development
- GMP & non-GMP testing
- Formulation Support
- Dissolution
- Metals Testing
- Physical Testing
- Mass Spectrometry and Unknown Identification
- NMR Analysis
- Solid-State Characterization Services
- Extractables & Leachables
- Release & Stability Testing
- Stability Storage
Clinical Supply Services
- Project & Clinical Supply Management
- Primary Packaging
- Secondary Packaging & Labeling
- Clinical Storage & Distribution
- Global Comparator Sourcing
FEATURED TECHNOLOGIES
- FormuPhase™ Solution Suite
- FormaDose™ Design Suite
- Prime Pharmaceutics™
- Pharma Prime Solution™
- ClinixSupply Total™
- RxReach™
- API Micronization
- Comprehensive Analytical Services
- Cryogenic Milling
- Mechanical Milling
- Particle Size Characterization
- Particle Size Engineering
- Clinical Supply Management
- Comparator Sourcing
- Primary Packaging
- Secondary Packaging & Labeling
- QP Release
- Clinical Storage
- Controlled Drug Storage
- Global Distribution
- Returns & Destruction
- Demand-Led Supply
- RxReach Direct-to-Patient (Site-to-Patient only)
- Formulation & Development
- Oral Commercial Scale Manufacturing
- Bioavailability Enhancement
- Controlled Release
- Full Analytical Support to Manufacturing
- Oral Technologies
- Bioavailability Enhancement
- Modified Release Formulation
- Orally Disintegrating Tablets
- Abuse Deterrent
ACCREDITATIONS
- FDA Approved
- MHRA Approved
- DEA approved
- GMP Facility
SALES INQUIRIES
Reach out to one of our experts to discuss any of our offerings or a specific solution for your project challenges.