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  Pharmaceutical Technology Europe E-Alert
 
24 September 2013
IN THIS ISSUE
News
Webcasts
Events
About Us
 
Featured Topics
FDA Works to Secure Drug Supply Chain
New policies aim to strengthen inspection and oversight processes. More...
 
EU Raises API Standards: A Curse in Disguise?
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain? More...
 
Top News Stories
EMA’s CHMP Recommends Approvals for 11 Medicines
CHMP recommended 11 new medicines for approval, the most approval recommendations at a CHMP meeting thus far in 2013. More...
 
CMDh Recommends Suspends Authorization for Numeta G13%E
The CMDh agrees to suspend the marketing authorization of Numeta G13%E because of a risk of hypermagnesaemia. More...
 
FDA Issues Import Alert Against Ranbaxy Laboratories
FDA issues import alert due to cGMP violations at Ranbaxy's facility in Mohali, India. More...
 
Roche Nominates New Chairman
Roche nominates Christoph Franz, currently CEO of the Lufthansa Group, to succeed current Roche chairman Franz B. Hummer. More...
 
European Medicines Agency Reorganizes
EMA releases details of restructuring. More...
 
Judge Approves Consent Decree Against Shamrock Medical Solutions Group
Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices. More...
 
In the News
Xofigo Injection Recommended for Approval in EU
The EMA Committee for CHMP recommends the approval of Xofigo in Europe. More...
 
Teva Signs R&D Pact with a UK Research Institute
The alliance with Teva will focus on mechanisms and molecular targets related to the emergence of treatment-resistant cancer cells. More...
 
Hospira Voluntarily Recalls Certain Lots of Bupivacaine
FDA reports that Hospira initiated on July 12, 2013 a voluntary recall of certain lots of bupivacaine HCl due to particulates floating and/or in the glass vial. More...
 
MIT Receives $10.4 Million BioManufacturing Grant
The Biomanufacturing Research Program (BioMAN) at Massachusetts Institute of Technology (MIT) has received $10.4 Million from the Defense Advanced Research Projects Agency (DARPA) to develop new technologies and manufacturing platforms that will provide an emergency supply of medicines for front-line military medics. More...
 
CDC Report Describes Antibiotic Resistance Threat
CDC says antibiotic resistance is a quickly growing and dangerous problem. More...
 
Webcasts
Meeting Regulatory and Technical Requirements for Organic Impurity Analysis
Tuesday, October 1, 2013 at 15:00 CET
Sponsored by: SGS Life Science Services
 
New Strategies for Evaluating BioPharmaceutical Stability
On Demand
Sponsored by: ABC Labs
 
Optimizing Quality by Design in Bulk Powders and Solid Dosage
On Demand
Sponsored by: Hovione
 
Accelerate Sterile and Non-Sterile Clinical Trial Manufacturing with Single-Use Technologies
On Demand
Sponsored by: Patheon
 
More Webcasts

Products/Services Profile
Agilent
Do More Together with Open Access Solutions
Agilent’s open access solutions enable pharmaceutical scientists to accelerate discovery by simplifying the management of multiple LC/MS and NMR instruments. New MassHunter Walkup Software allows analytical chemists to easily configure and maintain multiple MS instruments, spending more time doing other work. New Vnmr J 4 Persona Manager provides NMR facility managers with a flexible platform for managing multiple users and spectrometers. Attend a webinar. www.agilent.com/chem/togetherpharma#openaccess
FeF Chemicals
We manufacture Quats using only high purity tertiary amines with various alkyl chain lengths, normally ranging from C12 to C18.
We keep one step ahead of the current, global regulatory requirements, both in manufacturing (GMP, ISO), analysis (multicompendial pharmacopoeia) and documentation (CEP/COS, DMF, declarations). Read more.
Keofitt aseptic
The main products for this category is the unique single-use sampling bag systems allowing safe and aseptic sampling from any type of sterilizable sampling valve. Read more.
LB Bohle
The Bohle Fluid Bed System offers numerous advantages and various options in the pharmaceutical production without alteration of equipment setup. Through the tangential-spray technology, this processing design is much more robust than traditional Wurster technology. Read more.


Survey

This week we would like to know...

What anticounterfeiting tools are having the most significant effect on reducing the number of counterfeit pharmaceuticals in the legal supply chain?

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Spotlight Event

Validation Week
Industry's Most Comprehensive Event Dedicated to Validation Practice

Oct. 22-24, 2013
San Diego, CA

> Brochure
> Register

Other Validation Events
Method Development and Validation
a part of Lab Compliance Week
December 3-5, 2013 | Philadelphia, PA

More in GMP/Validation


Reference Library

Pharmaceutical Technology Drug Delivery Guides
A three-volume set of drug delivery system handbooks. A compilation of articles related to methods and processes of manufacturing and administering pharmaceutical compounds to achieve therapeutic effects.  Topics include the development of controlled-release formulations and reformulating injectable drugs for oral delivery. ... Click here


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