Catalent Pharma Solutions, Inc. - CMOCRO

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Catalent Pharma Solutions, Inc.

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Catalent Pharma Solutions, Inc.

Headquartered in Somerset, New Jersey, Catalent is one of the providers of advanced technologies, and development, manufacturing and packaging services for pharmaceutical, biotechnology and consumer healthcare companies in nearly 100 countries. The company applies its local market expertise and technical creativity to advance treatments, change markets and enhance patient outcomes.

Phone:

+1 877-587-1835
Fax:

732-537-6480
Email:

info@catalent.com
Website:

http://www.catalent.com
Address:

14 Schoolhouse Road Somerset, NJ 08873

USA
United Kingdom
Switzerland
South America
Latin America
Japan
Italy
Ireland
Germany
France
Europe
Brazil
Belgium
Australia
Asia
Argentina

Service Information

ANALYTICAL

API Type

Biological Controlled Substance High Potency Drug Small Molecule

Sample Type

API Cleaning/Validation Container/Closure Dosage form Raw Material

Service Type

Device Inhalation/Nasal Device Injection Device Elemental Analysis Methods Method Development Method Transfer Method Validation Reference Standard Certification Tests - Dissolution/Disintegration Disintegration Dissolution App. I/II Dissolution App. III Dissolution App. IV Tests - Impurities/Degradation Forced Degradation Imp./Deg Quantitation Tests - Physical Particle Size Physical Testing Tests - Protein/Peptide/DNA/Oligo Peptide mapping Protein Biophysical Characterization Protein Chemical Stability Protein Dosage Form Tests - Stability ICH/Commercial Stability Storage ICH/Commercial Stability Testing Stability Storage (I/II)Stability Testing (I/II)Tests/Analysis - Other Assay/Potency Comparator Analysis Compendial Testing Extractables/Leachables LCMS Analysis Moisture NMR Services Polymer analysis Residual Ethylene Oxide Residual Solvent Analysis Sample Analysis Thermal Analyses/DSC Trace Analysis Wet Chemistry

API/BIOLOGICS/REAGENTS

API Development Stage

Discovery GMP clinical Preclinical

API Services

Fermentation Process Dev.Scale-up

API Types

Biologics Antibody Protein Small molecule

Reagents

Reference Standards

BIO-ANALYTICAL

Services

Assays and Supplies Molecular Biology Immunoassay Immuno Biomarkers

CLINICAL DEVELOPMENT

Clinical Services Provided

Regulatory/Quality/Safety Qualified Person Release

CONSULTANT

Areas of Expertise

Research/Development Analytical Formulation Product Development Regulatory

DRUG DELIVERY DEVICES

Inhalation Devices

Canisters DPI MDI

FACILITY REGULATORY STATUS

Facility regulatory bodies

Facility subcategories

Inspected Licensed/registered

FORMULATION/MANUFACTURING

MICROBIOLOGICAL TESTING

Development Phase Micro

Clinical Commercial mfg Preclinical

Formulations Serviced

Biopharmaceutical Formulations Inhalation Injectable

Microbiology Services

Antiseptics and Antibiotic Testing Bacterial Endotoxin Testing Container Closure Testing Microbial Identification Microbial Limit Testing Particulate Matter USP Preservative Effectiveness Testing Sterility Testing Water Testing (USP)

PACKAGING/FILLING/LABELING

PREFORMULATION

REGULATORY

Formulation Category

Biopharmaceutical Formulations Combination Products Controlled Substances Cytotoxic Formulations Generics High Potency Drug Formulations Injectable Oral Pediatric Formulations Prefilled Syringe Topical

Regulatory Services

ANDA BLA CMC IND/CTA/IDE NDA

SUPPLY CHAIN MANAGEMENT

Supply Chain Services

Distribution Import/Export Inventory Management Product Storage Refrigirated Product Handling Supply Chain Management

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