Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Frontage Receives Approval for Manufacture of Schedule I and II Drug Products

Published: Tuesday, December 24, 2013
Last Updated: Tuesday, December 24, 2013
Bookmark and Share
Expands handling capabilities to all pharmaceutically relevant classes.

Frontage has announced that its CMC Services group has received approval from the Drug Enforcement Agency (DEA), a United States federal law enforcement agency under the U.S. Department of Justice, for manufacture of Schedule I and II drug products, expanding Frontage’s handling capabilities to all pharmaceutically relevant classes (Schedules I - V) regulated by the DEA.

The approval enables Frontage to conduct formulation development and Good Manufacturing Practices (GMP) manufacturing projects for many key medications used to treat pain and central nervous system (CNS) conditions.

Frontage provides organic synthesis, formulation development, GMP analytical testing, GMP clinical trial material manufacturing, clinical trial services and bioanalytical support of clinical and preclinical studies for all types of drug candidates ranging from novel, early phase projects to generic-equivalent and consumer care medications.

The DEA manufacturing license requires maintenance of a secure facility with precise monitoring and electronic access controls, specialized operating procedures, staff requirements and physical security.

“Together with our existing capabilities, technology and experience, this approval is significant in helping establish Frontage’s product development services as a center of excellence for pain management therapies,” said Dr. Dongmei Wang, General Manager, CMC Services.

Dr. Wang continued, “Pain adversely affects more than a billion people worldwide, and the science of pain management delivery keeps improving. We are committed to pursuing enhancements for effective and efficient development, as pain management products command a larger portion of our clients’ CNS pipelines.”

Frontage’s relevant experience ranges from conducting abuse deterrence studies (both clinically and analytically) and product development support for several different classes of pain relievers, including opioid compounds such as morphine, oxycodone, oxymorphone, hydromorphone and fentanyl, to non-steroidal anti-inflammatory compounds such as tramadol, naproxen sodium, ketoprofen, ibuprofen, and piroxicam, to anti-convulsant medications used as pain treatments, such as pregabalin, phenobarbital, midazolam, and oxcarbazepine.

Frontage helps biopharmaceutical organizations advance their research and development efforts with full service offerings- including bioanalysis, preclinical and clinical studies, analytical testing and product development support- spanning discovery stages through late-stage clinical trials.

The company also provides turnkey product development, bioequivalence and analytical services to generic and consumer health pharmaceutical companies to support Abbreviated NDA and 505.b.2 application submissions.

With a 12-year history of bioanalytical, clinical research and CMC operations, eight research facilities and more than 300 professionals in the US and China, Frontage has enabled biopharmaceutical and generic companies of all sizes to advance hundreds of molecules through clinical development and commercial launch in global markets.


Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,400+ scientific posters on ePosters
  • More than 3,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Toxin from Salmonid Fish has Potential to Treat Cancer
Researchers from the University of Freiburg decode molecular mechanism of fish pathogen.
New Diabetes Drug has Unexpected Side Effect
A type of drug used to treat diabetes may reduce the risk of developing Parkinson’s disease, according to new research.
Researchers Develop Vaccine that Protects Primates Against Ebola
A collaborative team from The University of Texas Medical Branch at Galveston and the National Institutes of Health have developed an inhalable vaccine that protects primates against Ebola.
Cannabis May Be Used to Treat Fractures
TAU researcher finds non-psychotropic compound in marijuana can help heal bone fissures.
A Novel Drug to FIght Malaria
An international team of scientists has announced that a new compound to fight malaria is ready for human trials.
New Cell Structure Finding Might Lead to Novel Cancer Therapies
University of Warwick scientists in the U.K. say they have discovered a cell structure which could help researchers understand why some cancers develop.
Creating More Potent Vaccines
Yale researchers uncovered a new role for a type of immune cell, known as regulatory T cells, in promoting long-term immunity.
Potential Therapeutic for Blinding Eye Disease
NIH research points to microglia as potential therapeutic target in retinitis pigmentosa.
Potential New Class of Cancer Drugs
Scientists have found a way to stop cancer cell growth by targeting the Warburg Effect, a trait of cancer cell metabolism that scientists have been eager to exploit.
Global Search for Next Antibiotic
University of Queensland researchers have launched a global search to discover antibiotics capable of combating superbug bacteria that are resistant to current antibiotics.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!