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

Join For Free

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 3,300+ scientific posters on ePosters
  • More than 5,000+ 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
New Way of Displaying 3D Molecular Structures
Metal-organic frameworks provide a new platform for solving the structure of hard-to-study samples.
Agent Blocks Pain Without Morphine's Side Effects
Scientists have synthesised a molecule with specific pain-relief properties and has shown its efficacy in mice.
Cutting the Cost of Drug-Building Chemicals
EPFL scientists have developed a method to produce aryl-containing amines in a cheap and easily scalable way.
How Cloud Connectivity Can Combat the Reproducibility Crisis
This infographic explains the reproducibility crisis, and how cloud connectivity can help overcome this problem.
Accessing Metabolic Information with Mass Spec
Scientists at the Helmholtz Zentrum München have developed a new mass spectrometry imaging method which, for the first time, makes it possible to analyze hundreds of metabolites in fixed tissue samples.
Simplifying Gene Testing Access for Ovarian Cancer Patients
Simplifying access to gene testing for women with ovarian cancer improves treatment choices and could save lives.
New Protein Model Could Accelerate Drug Development
Stony Brook-led international research team creates ultra-fast approach to model protein interactions.
New Method Opens Door to Development of Many New Medicines
Findings from TSRI reveal human proteins are better drug targets than previously thought.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Angina Drug Could Inform A New Strategy To Fight Cryptococcosis
A drug, more commonly used in the treatment of angina, could be the focus of a new strategy in fighting the fatal fungal infection cryptococcosis.
SELECTBIO

SELECTBIO Market Reports
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!