EMA Says Ben Venue's Anticancer Drugs Should be Manufactured in Another Facility - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

EMA Says Ben Venue's Anticancer Drugs Should be Manufactured in Another Facility


ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA’s review of all fourteen centrally authorized medicines that were produced at the site.

Presently, Ben Venue is the only facility that manufactures the anticancer medicines Caelyx (doxorubicin hydrochloride) and Ceplene (histamine duhydrochloride) for the European Union market. While the transfer takes place, the EMA has recommended that the marketing authorizations for both medicines be maintained because they are considered essential for patients and no alternative suppliers or formulations are available. The Agency also added that no concerns have been raised from the safety monitoring of these medicines.

For Caelyx, the EMA explained in a statement that no new patients should be started on the treatment. This recommendation will remain in place until the sterile filtration and aseptic filling processes have been transferred to a new manufacturing site, which should be completed by September 2012. Following this, Janssen-Cilag International NV, which is the marketing authorization holder, will transfer all the remaining steps in the manufacturing process to a new site by the end of 2014.

Janssen-Cilag is also required to promptly report any safety concerns, as well as submit a monthly report detailing reports on effects that could be related to sterilization problems.

For Ceplene, manufacturing processes must be transferred by the marketing authorization holder (EpiCept GmbH) by the end of 2013. In the meantime, the company must continue to visually inspect vials for signs of particle contamination.

The EMA’s Committee for Medicinal Products for Human Use has been reviewing medicines manufactured at Ben Venue since early November 2011 after an inspection identified problems in the company’s quality-management system, particularly in relation to the sterile filling process and possible particle contamination during manufacturing. The decisions regarding Caelyx and Ceplene mark the end of the review. For the previous twelve medicines in the review, the EMA recommended that Ben Venue be removed as a manufacturing site. The review also resulted in the suspension of the marketing authorizations for the skin infection medicine Vibativ and the diagnostic agent Luminity until a suitable, alternative manufacturing site is approved.

Ben Venue Laboratories is the manufacturing arm of Bedford Laboratories, which is a Boehringer Ingelheim company.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here