" "
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Abstral® Receives Japan’s MHLW Approval

Published: Tuesday, September 24, 2013
Last Updated: Tuesday, September 24, 2013
Bookmark and Share
Approval to manufacture highly potent compound for breakthrough pain relief in cancer treatment granted.

Recipharm Stockholm has announced that the company was informed on September 20, 2013 by the R&D-based pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (Tokyo, Japan, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) that Abstral® sublingual tablet (nonproprietary name: fentanyl citrate; referred to below as “Abstral®”), has been approved for manufacturing and marketing by Japan's Ministry of Health, Labour and Welfare(MHLW).

The approval allows Recipharm to carry out commercial scale manufacturing and packaging of Abstral® for supply to the Japanese market through Kyowa Hakko Kirin.

The drug product, Abstral® is a novel, highly potent, rapid disintegration, sublingual (under the tongue) formulation of fentanyl citrate.

This well-established opioid is used extensively for fast relief and management of episodes of breakthrough pain experienced by cancer patients that are already in receipt of opioid analgesics for cancer pain.

Japanese regulatory agency assessed Recipharm’s suitability through detailed analysis of the company’s history, capabilities, proven track record and the reliability of the supply chain set to take the product through to Japan, together with a thorough review of all clinical data and product documentation.

Recipharm will compress and formulate Abstral® in tablet dosage at its manufacturing site in Årsta, with all packaging performed at the company’s Jordbro complex. Quality control will be initiated in laboratories located in central Stockholm.

Thomas Beck, Director of Quality and Qualified Person at Recipharm Stockholm commented: “We are delighted to receive Japan’s MHLW approval to carry out a combination of both the manufacturing and the packaging of such a product, for onward supply to the Japanese market. Indeed, we are pleased, both because securing such authorization from a regulatory body outside of the EU is an extremely complicated process, especially in the case of Japan, and due to the fact that Abstral® is a highly innovative drug that enables fast relief of pain endured by patients undergoing cancer treatment.”


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 2,900+ scientific posters on ePosters
  • More Than 4,200+ 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.

Related Content

Recipharm Takes the Lead in Serialisation Challenge with €40m Investment
The company has unveiled that it plans to invest €40m over the next three years to ensure solutions for serialisation processes.
Thursday, February 11, 2016
Recipharm Presents 2016 International Environmental Award Winner
Jerker Frick won the award in recognition of his research into the environmental effects of pharmaceuticals.
Tuesday, February 02, 2016
Recipharm Appoints New Key Account Director for Europe
Company announces appointment of Anke Mollowitz.
Thursday, January 21, 2016
Recipharm Appoints General Manager
Company appoints Yves Buelens for its new blow fill seal subsidiary in Kaysersberg, France.
Saturday, January 09, 2016
Recipharm Signs Manufacturing Agreement with Alcon
Company acquires facility in France, adding new niche capabilities.
Tuesday, December 22, 2015
Recipharm and LIDDS Sign Contract
Contract for production of Liproca® Depot and investment in LIDDS.
Thursday, December 17, 2015
Recipharm Secures €25 Million Contract with Daewoong Pharmaceutical
Company has signed an agreement with Daewoong for the manufacture and supply of Erdosteine API.
Tuesday, November 24, 2015
Recipharm Announces Signing of an Agreement with Daewoong
Company secures €25 million contract for Erdosteine API with Daewoong Pharmaceutical.
Saturday, November 14, 2015
Recipharm to Acquire Majority Stake in Indian CMO Nitin Lifesciences
Company enters into an agreement to acquire Indian sterile injectables CMO, Nitin Lifesciences.
Wednesday, October 28, 2015
Recipharm Appoints New Business Director for Italy
Company also appoints new General Manager at Pessac, France.
Tuesday, October 27, 2015
Recipharm Reaches Agreement with LobSor Pharmaceuticals
Agreement to manufacture LECIGON™, a proprietary treatment for advanced Parkinson’s disease.
Thursday, September 10, 2015
Recipharm Signs Agreement with RedHill Biopharma
Agreement for manufacturing of RHB-105 for treatment of H. pylori infection.
Thursday, August 27, 2015
Recipharm Secures Additional Bank Financing for Continued Growth
Company has entered a new five-year SEK 1 500 million term loan facility with three of the largest banks.
Tuesday, July 14, 2015
Recipharm Invests SEK 8 Million in Pharmanest
Investment to support the development of Pharmanest’s lead drug candidate SHACT.
Friday, July 10, 2015
Recipharm Reduces Risk and Improves Compliance with Infor
Company will also help Recipharm continue to improve compliance with the EU-GMP code of practice.
Thursday, July 09, 2015
Scientific News
Retractable Protein Nanoneedles
The ability to control the transfer of molecules through cellular membranes is an important function in synthetic biology; a new study from researchers at Harvard’s Wyss Institute for Biologically Inspired Engineering and Harvard Medical School (HMS) introduces a novel mechanical method for controlling release of molecules inside cells.
Leukemia’s Surroundings Key to its Growth
Researchers at The University of Texas at Austin have discovered that a type of cancer found primarily in children can grow only when signaled to do so by other nearby cells that are noncancerous.
Common Cell Transformed into Master Heart Cell
By genetically reprogramming the most common type of cell in mammalian connective tissue, researchers at the University of Wisconsin—Madison have generated master heart cells — primitive progenitors that form the developing heart.
‘Smelling’ Prostate Cancer
A research team from the University of Liverpool and the University of the West of England (UWE Bristol) has reached an important milestone towards creating a urine diagnostic test for prostate cancer that could mean that invasive diagnostic procedures that men currently undergo eventually become a thing of the past.
Genetic Mutation that Prevents Diabetes Complications
The most significant complications of diabetes include diabetic retinal disease, or retinopathy, and diabetic kidney disease, or nephropathy. Both involve damaged capillaries.
A Crystal Clear View of Biomolecules
Fundamental discovery triggers paradigm shift in crystallography.
Could the Food we Eat Affect Our Genes?
Almost all of our genes may be influenced by the food we eat, according to new research.
NIH Seeks Research Applications to Study Zika in Pregnancy, Developing Fetus
Institute has announced that the new effort seeks to understand virus effect on reproduction and child development.
Iron in the Blood Could Cause Cell Damage
Concentrations of iron similar to those delivered through standard treatments can trigger DNA damage within 10 minutes, when given to cells in the laboratory.
Neanderthal DNA Influences Human Disease Risk
Large-scale, evolutionary analysis compares genetic data alongside electronic health records.
Scroll Up
Scroll Down
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
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!