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

SOURCE Colorcon, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:12/17/2014)...  ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) ... (USPTO) has issued a key patent covering ImmunoCellular,s ... targeting six tumor antigens that are commonly expressed ... 8,871,211, which issued October 28, 2014, include methods ... cell composition comprising peptide epitopes of the six ...
(Date:12/17/2014)... 17, 2014  RXi Pharmaceuticals Corporation (NASDAQ: ... discovering, developing and commercializing innovative therapies addressing major ... of enrollment in its first Phase 2a study, ... confirmed the 1-month findings that were reported in ... - http://photos.prnewswire.com/prnh/20130917/NE80755LOGO , , ...
(Date:12/17/2014)... -- PCCA received the Autism Hope Alliance,s (AHA) ... seal for best practices in meeting needs in ... materials and goods that meet strict criteria and ... by autism often have unique physical or psychological ... in food and medicine – for instance casein, ...
Breaking Medicine Technology:ImmunoCellular Therapeutics Announces Issuance of Key Patent For ICT-107 Cancer Vaccine 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 2RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 3RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 4RXi Pharmaceuticals Announces Sustained Effect of RXI-109 at Three Months Post Scar Revision Surgery and the Completion of Enrollment for its Phase 2a Trial RXI-109-1301 5Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 2Parents Of Children With Autism Spectrum Disorder Have New Options When Administering Medications 3
... term follow up results from chronically infected Hepatitis C,patients strongly confirm and exceed ... to show a statistically significant and long-term ... the way and strongly support move into a second generation, vaccine formulated ... ...
... the risk of,stroke by 34% in patient with atrial fibrillation ... adequately treated by ... of a,post-hoc analysis of the data from the ATHENA study ... European Society of Cardiology,congress 2008, in Munich, Germany. Previous results ...
Cached Medicine Technology:Favourable Six Months Follow-Up Results From Intercell's Phase II Therapeutic Hepatitis C Program 2Favourable Six Months Follow-Up Results From Intercell's Phase II Therapeutic Hepatitis C Program 3Favourable Six Months Follow-Up Results From Intercell's Phase II Therapeutic Hepatitis C Program 4Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation 2Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation 3Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation 4Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation 5
(Date:12/20/2014)... Developers of FCPX 3rd ... plugin for Final Cut Pro X entitled TranSlice Volume ... allows users to create hand drawn text animations without ... CEO of Pixel Film Studios. “TranSlice Volume 5 was ... an easy to use interface.” , TranSlice Volume 5 ...
(Date:12/20/2014)... Today, Balfleet.com, one of the most outstanding dressmakers in ... on its Mother of the Bride Dresses ... bride dresses from Balfleet.com feature gorgeous looks and delicate ... pride in providing high quality dresses to its clients ... on our mother of the bride dresses, and we ...
(Date:12/19/2014)... (PRWEB) December 19, 2014 Sub Zero Ice ... sponsor a blood drive Sunday the 28th from 2pm-6pm at ... & Sawyer Road in Sarasota, FL. , Inquiries regarding time ... you for participating in the donating process, Sub Zero Ice ... flash frozen, custom ice cream. , About Sub Zero Ice ...
(Date:12/19/2014)... CA (PRWEB) December 19, 2014 SuperCloset ... 5x5 SuperClone Rooms. SuperCloset continues to offer indoor growers ... Pair one of the new SuperClone Rooms with the ... perpetual, and turnkey indoor hydroponic grow room setup. , ... the world, SuperCloset’s SuperPonic SuperCloner 50 . ...
(Date:12/19/2014)... TX (PRWEB) December 20, 2014 The ... a new injectable filler from respected cosmetic brand Juvéderm. ... occur naturally with age. The Medspa at Hendrick is ... development in skin care technology to its clients. , ... gel to be FDA-approved to treat the mid-face and ...
Breaking Medicine News(10 mins):Health News:Pixel Film Studios released a new transition entitled TranSlice Volume 5 exclusively for Final Cut Pro X 2Health News:Balfleet.com is Offering 50%-70% Off of its Mother of the Bride Dresses 2Health News:Shark Tank’s Sub Zero Ice Cream Sponsors Blood Drive 2Health News:SuperCloset Continues to Innovate with New Complete Indoor Grow Room Packages, The SuperClone Rooms are the Newest Addition to the Award Winning SuperRoom Lineup 2Health News:Breakthrough New Injectable Dermal Filler Voluma XC Offered by The MedSpa at Hendrick 2
... Corporation,(Nasdaq: MDTH ) announced that its senior management ... 2008 Health Care Conference,held May 13 - 15 at ... senior management will give its presentation on Tuesday, May,13 ... web cast live over,the Internet via MedCath,s website ( ...
... TORONTO, May 9 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals ... development and,commercialization of cancer therapies, today announced ... Operational Highlights, During the three ... achieved the,following steps in preparation for the ...
... Two Operations Leads to Indictment of 11,Defendants in ... people have been,indicted in the second phase of ... and health care companies that,fraudulently bill the Medicare ... S. Fisher and U.S. Attorney for the Central,District ...
... May 8 HealthSouth,Corporation (NYSE: HLS ) today ... things, elect directors and provide an update on the,company,s ... More than 88.5% of the outstanding shares eligible ... or by proxy and the board,s,nominated slate of directors ...
... PHOENIX, May 8 NutraCea (OTC Bulletin Board:,NTRZ), ... nutrient research and,technology, announced today that it will ... 12 after the market closes., Management will ... Monday, May,12th to review the first quarter financial ...
... 8 Shortly after the gruesome,discovery of aborted babies ... in early March, Citizens for a Pro-Life Society,discovered the ... Advisory Clinic in Livonia, Michigan, owned by Dr. Reginald ... times in which we live that we,must stop and ...
Cached Medicine News:Health News:Bradmer announces 2008 first quarter operational and financial results 2Health News:Bradmer announces 2008 first quarter operational and financial results 3Health News:Bradmer announces 2008 first quarter operational and financial results 4Health News:Bradmer announces 2008 first quarter operational and financial results 5Health News:Bradmer announces 2008 first quarter operational and financial results 6Health News:Bradmer announces 2008 first quarter operational and financial results 7Health News:Bradmer announces 2008 first quarter operational and financial results 8Health News:Strike Force Targets Medicare Fraud By Los Angeles Area Health Care Companies 2Health News:Strike Force Targets Medicare Fraud By Los Angeles Area Health Care Companies 3Health News:Strike Force Targets Medicare Fraud By Los Angeles Area Health Care Companies 4Health News:Strike Force Targets Medicare Fraud By Los Angeles Area Health Care Companies 5Health News:HealthSouth Board Re-Elected at Annual Shareholder Meeting 2Health News:NutraCea to Host First Quarter 2008 Conference Call on May 12. 2Health News:ALL: More Dead Babies Found in Michigan Dumpsters 2
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: