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 3,900+ scientific posters on ePosters
  • More Than 5,300+ 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 Invests in its Italian API Facility
The facility has advanced technical transfer capabilities and expertise in the development of chemical processes and analytical methods up to registration on a global basis.
Thursday, November 10, 2016
Recipharm to Open New GLP Bioanalysis Laboratory in Sweden
The investment will see the opening of a 500 square metre purpose-built facility in next month.
Friday, October 21, 2016
Recipharm Announces Global Serialisation Collaboration
Company has announced partnership with Marchesini, SEA Vision and TraceLink to introduce new serialisation capabilities.
Thursday, June 23, 2016
Recipharm Unveils Serialisation Pricing Model
Company has unveiled plans to improve the affordability of serialisation, with the introduction of a novel pricing model aimed at keeping investment costs down for clients.
Tuesday, May 31, 2016
Recipharm Acquisitions Create Global CDMO Leader
Recipharm has announced that it has signed two separate agreements to acquire Kemwell’s pharmaceutical contract development and manufacturing (CDMO) businesses.
Tuesday, April 19, 2016
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
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Stem Cells in Drug Discovery
Potential Source of Unlimited Human Test Cells, but Roadblocks Remain.
Cancer Genetics: Key to Diagnosis, Therapy
When applied judiciously, cancer genetics directs caregivers to the right drug at the right time, while sparing patients of unnecessary or harmful treatments.
BGI Sequences Gingko Tree, Revealing Large, Highly Repetitive Genome
Researchers at BGI have sequenced the more than 10-gigabase ginkgo genome to find a high number of repetitive sequences as well as a number of gene clusters that appear to be involved in defense mechanisms.
Survey of New York City Soil Uncovers Medicine-Making Microbes
Microbes have long been an invaluable source of new drugs. And to find more, we may have to look no further than the ground beneath our feet.
Accelerating the Detection of Foodborne Bacterial Outbreaks
The speed of diagnosis of foodborne bacterial outbreaks could be improved by a new technique developed by researchers at the Georgia Institute of Technology.
Making Personalized Medicine a Reality
Groundbreaking technique developed at McMaster University is helping to pave the way for advances in personalized medicine.
Scientists Identify Unique Genomic Features in Testicular Cancer
The findings may shed light on factors in other cancers that influence their sensitivity to chemotherapy.
Top 10 Life Science Innovations of 2016
2016 has seen the release of some truly innovative products. To help you digest these developments, The Scientist have listed their top picks for the year.
Largest Resource of Protein-Protein Interactions
Researchers have developed the largest ever database of protein-protein interactions.
Scroll Up
Scroll Down

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
3,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!