Pharmaceutical Online The Magazine -- Fall Digital Edition 2009

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Pharmaceutical Online The Magazine, Fall Issue

• Launch Date: October 2009
• Tradeshow Distribution: ISPE, AAPS and Pittcon 2010

Current Issue Table Of Contents:
• From The Publisher
• New Inhaled Liposomal Cyclosporine: A Formulation Gives Hope For Lung Transplant Recipients
• Advanced Size Exclusion Chromatography Beneficial To Pharmaceutical Development
• Using Terahertz Pulsed Imaging Optimizes Coating Parameters
• Instrumentation For Product Control Vs. Process Control
• Glass-Lined Side Baffles Boost reactor Flexibility, Efficiency
• The State Of The Art In Powder Filling For Pharmaceutical, Biotech, And Nutritional Dry Products
• Loss-In Weight Feeding And Continuous Extrusion
• Sequence-Based Analysis Enables Manufacturers To Develop And Maintain A Relevant, Validated Library 
• An Alternative Approach To Laboratory Fume Hood Design Results In Energy Savings, Safety Standards
• Quality Manufacturing Leads To Efficiencies, Profits


• Submit editorial to: themagazine@pharmaceuticalonline.com
• Contact Rich Ranus for advertising information


Pharmaceutical Online The Magazine — Digital Edition

2009 Pharmaceutical Online The Magazine  • Online Buyer's Guide Index  • Online Buyer's Guide 

Click The Logos To Visit Our Advertisers On The Web

Accugenix

Bionique Testing Laboratories, Inc.

Hospira Worldwide, Inc.

International Centre for Diffraction Data
 INTERPHEX 2010

Natoli Engineering Company, Inc.

Patheon Inc
 Rees Scientific

 
 

Online Buyer's Guide Index:

AUTOMATED ENVIRONMENTAL MONITORING
  Rees Scientific 

COMPONENTS/SINGLE-USE
  
Gore PharmBIO Products

CONTRACT ANALYTICAL/
MFG./PACKAGING

  
Sancilion & Company, Inc.    

CONTRACT MANUFACTURING
  
Patheon Inc

CONTRACT MANUFACTURING
AND TESTING

  
Bionique Testing Laboratories, Inc.
  Hospira Worldwide, Inc.
  SCYNEXIS, Inc.

DATABASES
  
International Centre for Diffraction Data


   

DATALOGGERS
  
Mesa Laboratories, Inc.

FILLING EQUIPMENT
  
CAPSUGEL

GRANULATION AND
PARTICLE SIZING

  
Clemex Technologies, Inc.    

INDUSTRY EVENT
  
Reed Exhibitions

LABORATORY EQUIPMENT
  
Applikon Biotechnology

LIMS Software 
  
Thermo Fisher Scientific

LYOPHILIZATION
  
Anteco Pharma

MICROBIOLOGY TESTING
  
Accugenix

PHARMACEUTICAL DEVELOPMENT
  Advantar Laboratories, Inc./
   NextPharma Technologies

PHARMACEUTICAL PACKAGING
AND LIQUID

  
McKesson RxPak

POWDER PROCESSING
  
Harro Hofliger Packaging Systems

TABLET EQUIPMENT AND
ACCESSORIES

  
Natoli Engineering Company, Inc.


Online Buyer's Guide

AUTOMATED ENVIRONMENTAL MONITORING

COMPONENTS/SINGLE-USE

Rees Scientific

Rees Scientific has been providing automated temperature monitoring solutions for over 25 years. Our systems are designed with loss prevention and compliance in mind. Rees Scientific Centron Environmental Monitoring Systems answer the critical equipment monitoring and alarming challenges faced by today's pharmaceutical industry. As an ISO 9001:2000 company, Rees Scientific is constantly upgrading policies, procedures, and protocols to comply with today's highly regulated environments. Rees helps clients meet critical, GxP, FDA, USP797, and other regulatory requirements. Our live, 24/7/365 technical support team ensures needs are responded to promptly and closed out correctly. Our project managers, customer, and technical support teams are experienced and dedicated to our customers. Together, they ensure that your system is well maintained, up-to-date, and working properly. Our goal remains sharply focused to ensure that your critical equipment and devices are monitored and maintained to set a standard every second of every day, without exception and without fail.

Rees Scientific
1007 Whitehead Road Extension
Trenton, NJ 08638
PH: (609) 530-1055
FX: (609) 671-2751
sales@reesscientific.com

 

 

 

 

 


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Gore PharmBIO Products 

Gore PharmBIO Products — Single-Use Components

The Gore product portfolio includes single-use components that enable the safe transfer, containment, and sampling of sterile liquids as well as high-purity solutions for SIP and CIP applications in long-life, highly durable form and packaging solutions.Gore tubing, hoses, connectors, manifolds, sampling and collection systems, and custom molded components are manufactured in a cleanroom operation. GORE™ STA-PURE™ Pump Tubing effectively resists the mechanical stress of peristaltic pumps.
Using Gore's online configuration tool allows customers to minimize fluid assembly system design time while providing fully customizable design options specific to various process needs. The GORE™ STA-PURESM Bioprocess Configurator is available 24 hours per day, 7 days per week.
GORE™ LYOGUARD® Freeze-Drying Products improve lyophilization processes while reducing product and freeze-dryer contamination risk.
GORE® Filtration Products help to optimize product collection of pharmaceutical dry powders as well as dust emissions.
GORE™ Microfiltration Media enables pharmaceutical filter manufacturers to engineer high-performing, reliable filters.
GORE™ Packaging Vents facilitate closed, pressure- equalized systems for multidose drug packaging applications.

Gore PharmBIO Products
402 Vieve's Way
Elkton, MD 21922
PH: (800)294-4673
pharmbio@wlgore.com
www.gore.com/pharmbio


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CONTRACT ANALYTICAL/MFG./PACKAGING

CONTRACT MANUFACTURING

Sancilio & Company, Inc.

SCI provides expert pharmaceutical contract services as follows:
Analytical Testing — Our modern laboratories provide a broad range of quality control, method development, validation, HPLC, GC, GC/MS, dissolution, and product support analytics.
Stability — Our new walk-in rooms and stability chambers provide a complete array of conditions to meet any regulatory specification. Chambers are monitored 24 hours a day, and have generators.
Contract Manufacturing — Fully compliant cGMP manufacturing capability, from thousands to millions of dosages of product, in temperature and humidity controlled suites, using state-of-the-art machines. We manufacture tablets, capsules, and soft gelatin capsules.
Packaging — We package tablets and capsules on high-speed packaging lines, or provide you with small quantities of packaged material for your clinical trials.
Blister Packaging — Our high speed blister packaging line produces commercial or clinical quantities of aluminum/plastic cards to fit your specific need.

Sancilio & Company, Inc.
73874 Fiscal Ct, Suite 200
Riviera Beach, FL 33404
PH: (561) 741-6500
FX: (561) 847-2312
info@sancilio.com
www.sancilio.com

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Patheon Inc

Patheon Delivers With New Performance-Based Contracts In 2008, Patheon set out to become the best Contract Development and Manufacturing Organization (CDMO) in the industry. The executive team — led by CEO and president Wesley P. Wheeler — determined a new course for the company.Now, in 2009, Patheon has achieved significant progress, exemplified by the company's most recent KPIs: Batches Right First Time average through July is 92% throughout all sites, and the On Time Delivery average through July is 94% network-wide. These numbers are unmatched in the industry.For Patheon's customers this equals security of supply and unparalleled quality for their products. Patheon is so confident that it's now offering the Patheon Performance Guarantee, backed up by new performance-based contracts. The company is also offering current contract reviews and special tech transfer pricing. For more information, contact a Patheon representative or email Patheon at doingbusiness@patheon.com.

 

Patheon Inc
PO Box 110145
Research Triangle Park, NC 27709-5145
doingbusiness@patheon.com
www.patheon.com

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CONTRACT MANUFACTURING AND TESTING

CONTRACT MANUFACTURING AND TESTING

Bionique Testing Laboratories, Inc.

Mycoplasma Testing Services

Bionique® Testing Laboratories, Inc. is a leading global organization specializing in the testing of cell cultures and biologicals for mycoplasmal contamination. The company has been providing mycoplasmal testing services, diagnostic kits, and consultation to pharmaceutical companies, biotechnological companies, research institutions, and media/sera manufacturers since 1983. Bionique plays a critical role in the success of its clients by assuring the integrity of their cell lines and the biosafety of their final product.
Our core services include direct culture, indicator cell lines, DNA-fluorochrome assays, antibiotic sensitivity profiles, validation studies, mycoplasmal elimination, and contractual research and development services. Kits include the exclusive CELLshipper® and Control Slides. Bionique Testing Laboratories has the capabilities and expertise to provide timely and reliable results at an affordable price.

Bionique Testing Laboratories, Inc.
156 Fay Brook Drive, Saranac Lake, NY 12983
PH: (518) 891-2356
FX: (518) 891-5753
www.bionique.com

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Hospira Worldwide, Inc.

Hospira is a global, specialty pharmaceutical and medication delivery company. The company's One 2 One business is a world leader in the custom development and manufacture of parenteral products packaged in vials, prefilled syringes, cartridges, flexible containers, and ampules.
One 2 One offers development and manufacturing services at its worldwide facilities located in North America, Europe, and Australia. With more than 70 years of parenteral manufacturing experience, One 2 One is known for its customer service orientation.

Hospira Worldwide, Inc.
275 North Field Drive, D-0988, Bldg. H-1
Lake Forest, IL 60045
PH: (224) 212-2267
FX: (224) 212-3210
one2one@hospira.com
www.one2onecmo.com

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CONTRACT MANUFACTURING AND TESTING

DATABASES

SCYNEXIS, Inc.

SCYNEXIS, Inc. is a premier drug discovery and development company delivering effective and innovative drug pipeline solutions to human and animal health pharmaceutical and global health partners. Our drug discovery and development services take your compounds from concept to clinic with speed and innovation. Our contract research and manufacturing services are available on a fee-for-service basis or may be conducted in a shared-risk arrangement. SCYNEXIS is headquartered in Research Triangle Park, NC, and occupies more than 120,000 sq. ft. of laboratory and office space strategically located in close proximity to RDU International Airport, UNC-Chapel Hill, Duke University, and North Carolina State University. SCYNEXIS is registered with the FDA and DEA. Our expertise areas include:
Medicinal Chemistry and Drug Discovery
ADMET-PK and Bioanalytical Testing
Process Chemistry and Chemical Development
Process Scale-Up
cGMP API supply
For more information, visit us on the Web at www.scynexis.com.

SCYNEXIS, Inc.
3501 C Tricenter Boulevard
Durham, NC 27713
PH: (919) 544-8600
Contract Research Service Contacts:Terry Marquardt
Bryce Chaney, MBA
Market.Development@scynexis.com

 

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International Centre for Diffraction Data


Organic Materials AnalysisPDF-4/Organics 2010 is designed for rapid materials analysis of organics and organometallic materials and their common formulations. While PDF-4/Organics contains predominantly organic and organometallic materials, it also contains thousands of reference data for polymeric and inorganic excipients, common inorganic salts, and starting materials. We have added all the types of materials typically found as reaction products and formulation ingredients.
Applications
Material Identification
Quantitative Analysis
Formulation Analysis
Polymorph Identificationu Salt, Solvate, and Hydration Analysis
Crystallite Size Analysis
PDF-4/Organics Content
~400,000 material data sets, edited and standardized for rapid identification
20 subfiles, including excipients, pharmaceuticals, and forensics
I/Ic values for quantitative analysis
Digital pattern simulations for crystallite size and total pattern analysis
An extensive compilation of known polymorphs, hydrates, and solvates for commercial drugs

Visit ICDD's website for publications related to the technology and applications of the Powder Diffraction File.

http://www.icdd.com/support/references/default.htm

International Centre for Diffraction Data
12 Campus Boulevard, Newtown Square, PA 19073
PH: (610) 325-9814
FX: (610) 325-9823
marketing@icdd.com
www.icdd.com

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DATALOGGERS

FILLING EQUIPMENT

Mesa Laboratories, Inc.


Mesa Laboratories, Inc. offers high-quality data loggers for monitoring temperature, humidity, and pressure and specialty biological indicators (BIs) for medical device and pharmaceutical manufacturing. DataTrace and Raven products are available to accurately monitor and validate EO and/or steam sterilization, autoclave validation, incubators, heat tunnels, and more.
DataTrace is a line of NIST traceable, high-quality data loggers that are the ideal wireless solution for the validation and monitoring of temperature, humidity, and/or pressure within a process or vessel. With a potential temperature range of -80°C to +400°C, the DataTrace Micropack Radio Frequency (MPRF) temperature logger provides real-time data in a compact, wireless unit.
Raven biological indicators are used to assess the effectiveness of sterilization processes including steam, EO, H2O2, dry heat, and a host of medical device and pharmaceutical manufacturing applications. Services such as organism identification, population verification, sterilization process development, and custom biological indicator production are also available.

Mesa Laboratories, Inc.
Lakewood, CO 80228
Primary sales contact: Roberta Stjernholm
PH: (303) 987-8000
FX: (303) 987-8989
datatracesales@mesalabs.com

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CAPSUGEL


Xcelodose® S Precision Powder Micro-Dosing SystemWith the Xcelodose® system, creating manufacturing batches for clinical trials and small-scale production has never been easier or more precise. That's because this unique technology allows companies to fill capsules with drug substances alone, thereby eliminating the need for excipient compatibility and preformulation activities.Xcelodose® Benefits
Even ‘Faster Time to First in Man' with precision, speed, and accuracy
Fills with precision at speeds of over 600 capsules/hour at ~2% RSD — approximately 10x faster than filling by hand
Allows filling of API direct into capsules, with no need for excipients, and can thereby save up to 6 months of development time by reducing the need for formulation development and stability testing
Accurate drug records for the monitoring of batches and individual capsules — the weight of each capsule and event is recorded
Doses as low as 100 micrograms for precise drug trials
Capsule size change can be achieved in minutes — change parts sizes 00 to 4 available u Wide range of optional extras and accessories available.

CAPSUGEL
535 North Emerald Road
Greenwood, SC 29646
PH: (888) 783-6361
FX: (888) 783-6360
Marketing.Amer@pfizer.com
www.capsugel.com


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GRANULATION AND PARTICLE SIZING

INDUSTRY EVENT

Clemex Technologies, Inc.


Listening to the needs and expectations of our customers is a principle we live by. In partnership with industry, we continue to improve, evolve, and adapt our instruments to new and higher standards. This flexibility has allowed us to build a solid reputation for excellence in the field of automated imaging systems. Our commitment to intelligent microscopy is reflected by the presence of our high-quality, customized solutions in quality control and research laboratories around the globe. We are committed to deliver the most cost-effective image analysis solutions, serving your needs through every step of production, from cleanrooms to finished products. Our compliance to standards such as ISO 13322, ISO 4406, ISO 4407, ISO 16232, IEST-STD-CC1246D, and USP 788 ensures that your analyses will measure up. After 20 years, our expertise in all types of imaging solutions is relied upon by customers from various industries — over and over again.

Clemex Technologies Inc.
800 Guimond
Longueuil, Quebec J4G 1T5, Canada
PH: (888)/(450) 651-6573
info@clemex.com
www.clemex.com

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INTERPHEX 2010


INTERPHEX is where the industry comes together to:
SOURCE. Meet face-to-face with leading industry suppliers and service providers showcasing the latest innovations, equipment, and solutions that are helping advance our industry.
ENHANCE KNOWLEDGE. Participate in an educational program with sessions designed to sharpen the skills you and your company need to excel in an ever-changing industry.
EXCHANGE IDEAS. Share insights, ideas, and best practices with leaders from across our industry. 

Reed Exhibitions
383 Main AvenueNorwalk, CT 06851
PH: (888) 334-8704
inquiry@interphex.com
www.interphex.com/PharmOnline

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LABORATORY EQUIPMENT

LIMS SOFTWARE

Applikon Biotechnology, Inc.

This year, at the 25th annual FEW in Denver, CO, Applikon introduced the Alcohol Fermentation Monitor — a small-scale fermentor system with six 500 ml vessels that accurately measures feedstock conversion rates in real time. The data collected allows operators to make critical comparisons between feedstock variations, host strain variations, and monitor other process condition changes at a small and manageable scale.This product also offers benefits for the brewery and distillery industries. Testing yeast fermentation performance is extremely useful for testing the real degree of fermentability of worts produced according to different recipes.

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Informatics Software

Thermo Scientific Darwin LIMS™ is specifically designed to address the unique needs of pharmaceutical manufacturing and research and development QA/QC labs. Darwin's unique batch- and product-oriented design aligns directly with pharmaceutical manufacturing processes, allowing research and development and production data to be logically organized, summarized, and reported. The substantial costs and risks associated with customizing a generic laboratory information management system (LIMS) to serve the needs of pharmaceutical manufacturing have given rThermo Fisher Scientificise to the trend toward out-of-the-box, or purpose-built, software solutions like Darwin.
The benefits of application-specific LIMS are
obvious: less customization means dramatically reduced implementation, training, validation, and maintenance costs — for a lower total cost of ownership and higher end-user acceptance.

Thermo Fisher Scientific
1601 Cherry St., Suite 1200, Philadelphia, PA 19102
PH: (215) 964-6020
FX: (215) 964-6021
marketing.informatics@thermofisher.com

www.thermo.com/informatics

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LYOPHILIZATION

MICROBIOLOGY TESTING

Anteco Pharma

Anteco Pharma specializes in GMP compliant formulation, lyophilization, and packaging for the pharmaceutical, medical device, and nutritional ingredient industries. Our focus is innovation, flexibility, and quick response. Our strengths are a validated, state-of-the-art facility, an experienced staff with a track record of success, and a fully compliant quality system. We are now ISO 9001 and ISO 13485 certified and registered with the US FDA as both a drug and a medical device manufacturer.

Our services include:
• Lyophilization capacity from 1 to 2,000 liters
• ISO 7 manufacturing suites
Formulation
Packaging
Process development, scale-up, and transfer
Project management and compliance support

Anteco Pharma's quality system is compliant with international drug, medical device, food, and dietary supplement GMPs. Customer, third party, and regulatory audits are encouraged and supported.
Let us show you how we can use these resources to provide cost-effective solutions to your most challenging manufacturing problems.

Anteco Pharma
925 Development Drive, PO Box 100
Lodi, WI 53555
PH: (608) 592-6925
FX: (608) 592-7925
info@antecopharma.com
www.antecopharma.com

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Accugenix, Inc.

Accugenix, Inc. provides leading-edge technology in microbial identification and characterization services. Our FDA-registered lab is cGMP compliant and maintains rigorous standards competitive at the global level. We specialize in testing, analyzing, and interpreting data from environmental isolates commonly found in pharmaceutical, biotechnology, medical device, neutraceutical, personal care, and other manufacturing industries. For more than 20 years, Accugenix has provided the fastest, most accurate and reliable microbial identification services to over 400 facilities around the world. Accugenix updates its validated, proprietary DNA sequence libraries annually to reflect current taxonomy and newly described relevant species. We have the industry's first fungal library based on the ITS region. Since inception, we have tested more than 300,000 microorganisms — more than any other service laboratory in the industry — while maintaining an on-time delivery of over 99%. Visit www.accugenix.com or call (800) 886-9654 or +49 (0) 621-3709-556. Accugenix — the leader in genetic microbial identification.

Accugenix, Inc.
223 Lake Drive, Newark, DE 19702
PH: (800) 886-9654 or (302) 294-8511
marketing@accugenix.com
www.accugenix.com

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PHARMACEUTICAL DEVELOPMENT

PHARMACEUTICAL PACKAGING AND LIQUID

Advantar Laboratories

Scientific knowledge, unparalleled experience, and best-in-class service — reap these benefits and more when you take advantage of the new partnership between Advantar Laboratories and NextPharma. Working together, our firms can provide the full spectrum of contract laboratory and manufacturing services for your small to mid-size company. From sterile contract manufacturing, clinical trials, packaging, cold chain storage, and distribution, to high-quality analytical development and testing, our team of experienced scientists has the knowledge and capability to drive your project forward and ensure deadlines are met. Work smarter, not harder. Call Advantar Laboratories to see how we can help you streamline your development program and save you time and money today!

Advantar Laboratories, Inc.
3030 Bunker Hill, Suite 102
San Diego, CA 92109
Contact: Robert G. Bergstrom, Ph.D
PH: (858) 750-0030
www.advantarlabs.com

NextPharma Technologies
5340 Eastgate Mall, San Diego, CA 92121
Contact: Rich Masino
PH: (858) 450-3123
www.nextpharma.com

 

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McKesson RxPak

What does your packaging say about your product?
McKesson RxPak understands how hard you've worked to build your brand's reputation with consumers. And we know how important it is to continue strengthening this reputation. You can trust us to ensure that your image reflects your commitment to high standards.
A leading provider of packaging products and services, McKesson RxPak provides today's top pharmaceutical companies with:
Proven expertise in compliance and consumer-friendly packaging for children and seniors
A wide array of contract services: compliance, blister, bottling, secondary packaging, and more
Commitment to the highest security standards

A Compliance Packaging Leader
McKesson RxPak has joined forces with Burgopak Ltd., the UK's foremost packaging innovator, to bring Burgopak's award-winning pharmaceutical compliance packaging to the United States. Burgopak's patented, simple-to-handle packaging design can help improve medication adherence and product safety, and is available in a sliding tray or blister pack.

For more information, please visit www.rxpak.com.

McKesson RxPak
4971 Southridge Blvd., Memphis, TN 38141
PH: (901) 255-8001
Kevin.Carter@McKesson.com
www.rxpak.com

 

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POWDER PROCESSING

TABLET EQUIPMENT AND ACCESSORIES

HArro Hofliger Packaging Systems


Harro Hofliger is a dynamic organization, widely recognized as a high-end supplier of production and packaging equipment, primarily to the pharmaceutical and medical device industries. In addition to our standard products, we provide innovative, custom solutions to meet the needs of our valued customers. We have delivered equipment to assemble and package an array of applications such as:

Capsule filling
Transdermal patches
Capsule and tablet weighing
Wound dressings
Powder handling and dosing
Dissolvable oral film strips
Liquid and powder inhalers
Diagnostic test strips
Wallet packs for blisters
Pouching
Side and top-load cartoning
Aseptic assembly
And many other products with nonstandard requirements 

At Hofliger, quality begins with the first design concepts and continues through to the finished product. We bring specialized technical knowledge, machine building expertise, and full-service customer support to every project. 

Harro Hofliger Packaging Systems
1 Edwards Court, #101
Burlingame, CA 94010
350 S. Main Street, Suite 315
Doylestown, PA 18901
Contact: John Van Tol
PH: (215) 345-4256
jvantol@hofliger.com
www.hofliger.com

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Natoli Engineering Company, Inc.

Established in 1973, Natoli Engineering Company is the world's premiere manufacturer and supplier of tablet compression tooling, accessories, presses, parts, software management, and services for the pharmaceutical, nutritional, industrial, and confectionary industries. Our dedication to excellence, combined with steadfast determination, innovative thinking, and a commitment to providing the best customer service, has propelled us to the forefront of the tablet compression industry.
Products:
Tablet compression tooling
Tablet compression accessories
Tablet compression accessories catalog
Tablet presses
Tablet press replacement parts and turrets
Tool management software

Services:
Tooling and tablet design
Tooling evaluation/repairs
Technical support and troubleshooting
Technical training
Expedited manufacturing and worldwide delivery

Natoli Engineering Company, Inc.
28 Research Park Circle, St. Charles, MO 63304
PH: (636) 926-8900
FX: (636) 926-8910
sales@natoli.comwww.natoli.com

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