Navigation Links
Colorcon, Inc. Quality by Design (QbD) Expertise Beneficial in Compliance with New FDA Guidelines
Date:9/19/2012

WEST POINT, Pa., Sept. 19, 2012 /PRNewswire/ -- Colorcon, Inc., (http://www.colorcon.com) a world leader in the development and supply of formulated coatings and other excipients for the pharmaceutical and nutritional supplement industries, announces customer access to valuable expertise in film coating formulation and process applications to assist pharmaceutical manufacturers with their Quality by Design (QbD) initiatives. Starting in January 2013, the FDA expects drug manufacturers to implement QbD principles in their Abbreviated New Drug Applications (ANDA).  The FDA QbD guidelines provide guidance on pharmaceutical product development and manufacturing to facilitate design of products and processes that maximizes the product's efficacy and safety while enhancing product manufacturability.

"For more than fifty years, Colorcon has remained a credible, industry-leading, partner in the development of fully formulated coating systems and has worked alongside formulators and drug product manufacturers while offering superior technical support," said Kamlesh Oza, General Manager, Film Coatings. "This plethora of experience puts Colorcon at the forefront in providing customers with industry leading insight into QbD principles for film coating.  Pharmaceutical companies can feel confident knowing that QbD principles have been used to develop and manufacture robust Opadry® fully formulated film coating products and systems in all Colorcon facilities world-wide that are consistent, predictable, reliable and controlled."

Colorcon has resources available for its customers as they prepare to meet the new FDA expectations.  Additionally, to provide its customers with valuable technical knowledge, Colorcon has hosted a series of webinars on the topic of QbD for the Pharmaceutical Industry.  To access previous webinars, please visit http://www.colorcon.com/formulation/education/webinars.

About Colorcon Colorcon is a world leader in the development, supply and support of formulated products for the pharmaceutical and nutritional industries. Its core businesses include film coatings, modified release technologies, functional excipients and tablet design services. Colorcon has 18 technical service laboratories globally and more than 1,200 employees exclusively dedicated to its customer base.

For additional information, visit http://www.colorcon.com. CONTACT:Diane ReitterGlobal Communication Directordreitter@colorcon.com215-661-2639


'/>"/>
SOURCE Colorcon, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Staffing and Performance Benchmarks for Quality Function Highlight New Medical Device Study
2. Millstone Medical Outsourcing Hires New Vice President Quality
3. Accident Fund Holdings Aims to Improve Control of Drug Utilization and Quality of Care with Change in Pharmacy Benefit Manager
4. FREEDOM Study Data: Patients Experience Sustained Quality of Life Benefits with More Frequent Home Hemodialysis with the NxStage System One
5. CyberKnife® Prostate SBRT Outcomes and Quality of Life Data Presented at American Urological Association Meeting
6. Lilly Expands Strategic Partnership with Chinese Manufacturer Novast to Serve Chinese Patients with High-Quality Branded Generic Medicines
7. Total Therapeutic Management, Inc. invites directors of quality improvement to learn secrets of provider engagement strategies
8. NeuroSigma Receives Global Quality Control Certification
9. Health Diagnostic Laboratory, Inc. (HDL, Inc.) Brings Advanced Testing to Capitol Hill, Discusses Health Care Cost Savings and Quality Improvement Potential
10. FDAnews announces Fourth Annual Supplier Quality Congress
11. New Plastic Blood Culture Bottles Increase Lab Convenience While Maintaining High-Quality Standards
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... PHILADELPHIA , Oct. 2, 2017 Halo Labs announces ... particle analysis system called the HORIZON at MIBio 2017 in ... analyzes subvisible and visible particulate matter in biopharmaceutical samples with unprecedented ... use of the novel technique Backgrounded Membrane Imaging. ... The HORIZON subvisible particle analysis system ...
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a ... of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners ... October 11, 2017. , The annual award competition recognizes editorial and design excellence across ...
(Date:10/12/2017)... ... 12, 2017 , ... On Saturday, October 21, the Health & Wellness Center ... to raise money for the American Heart Association Heart Walk. Teams of up to ... together to keep their treadmills moving for 5 hours. Treadmills will start at 7:00 ...
(Date:10/12/2017)... ... October 12, 2017 , ... Health Literacy Innovations ... literacy software tool, and the Cancer Patient Education Network (CPEN), an independent professional ... announce a new strategic alliance. , As CPEN’s strategic partner, HLI will ...
(Date:10/12/2017)... FL (PRWEB) , ... October 12, 2017 , ... ... presenting the latest in wound care advancements to physician colleagues, skilled nursing facility ... is titled, "Navigating the Treacherous Waters of Wound Care." , "At many of ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... its enhanced Pepper Flow promotional review platform at the Promotional Review Committee ... insight-driven capabilities help marketers streamline the medical, legal, and regulatory review (MLR) ...
Breaking Medicine News(10 mins):