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:5/24/2016)... CHRISTCHURCH, New Zealand , May 24, 2016 ... scanning and informatics solutions for the healthcare sector, has been ... the New Zealand Hi-Tech Awards 2016. Dr ... a fantastic acknowledgement for our team.  It,s really good to ... the burden healthcare internationally. Our products are used in 35 ...
(Date:5/24/2016)... VMS BioMarketing as senior vice president of sales, announced Andrea Heslin Smiley , ... the company,s business development and sales team, exploring new opportunities for VMS to empower ... ... ... ...
(Date:5/24/2016)... 24, 2016 ... , la première endoprothèse à double thérapie ... l,intervention portant sur les membres inférieurs et ... OrbusNeich, entreprise mondiale spécialisée dans la fourniture ... vie, a élargi son portefeuille pour inclure ...
Breaking Medicine Technology:
(Date:5/26/2016)... ... May 26, 2016 , ... There are nearly 14.5 million people living ... survivors worldwide. On Sunday, June 5, 2016, communities around the world will gather to ... , National Cancer Survivors Day® is an annual worldwide Celebration of Life that ...
(Date:5/26/2016)... ... May 26, 2016 , ... Catalent Pharma ... drugs, biologics, consumer health and global clinical supply services, today announced two key ... the company’s continued investment and strategic growth plans in the Asia Pacific region. ...
(Date:5/26/2016)... ... May 26, 2016 , ... An April Gallup survey ... , The 550 employees of Sun Health Senior Living (SHSL) may not ... reduces their doctor and prescription copays for the year, while holding the line on ...
(Date:5/26/2016)... ... May 26, 2016 , ... Memorial Day Weekend marks the unofficial ... is sharing tips to make sure your family and vehicle are ready to ... Council, there may be 439 deaths and an additional 50,500 serious injuries from motor ...
(Date:5/26/2016)... BELLEVUE, Wash. (PRWEB) , ... May 26, 2016 ... ... a trusted provider of comprehensive treatment for eating disorders, is opening a brand ... facility will provide individuals ages 8-17 and their families with even more specialized ...
Breaking Medicine News(10 mins):