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  Pharmaceutical Technology Europe E-Alert
 
20 September 2010
IN THIS ISSUE
• REACH deadline
 • EMA trials framework
• BMS acquisition
 • Actavis biosimilars interest
 
REACH deadline looming
The European Commission has issued a last call for REACH (Registration, Evaluation, Authorisation and restriction of Chemicals) registration; an EU initiative targeting companies that import or produce chemicals, which will ultimately impact a number of industries, including pharmaceuticals.. More...		  
 
EMA recommends global trials framework
The European Medicines Agency (EMA) has discussed the possibility of a global framework for clinical trials at an international workshop, given the fact that the majority of clinical trials for medicines approved in Europe are conducted outside of the EMA’s regulatory reach. More...		  
 
Bristol-Myers Squibb to acquire ZymoGenetics
Bristol-Myers Squibb (BMS) has agreed to acquire the biopharmaceutical company ZymoGenetics for an aggregate purchase price of $885 million in a move that will provide BMS with additional biologic compounds for its drug pipeline. More...		  
 
Actavis signals interest in biosimilars market
The generic-drug company Actavis (Iceland) is considering a proposed acquisition of a 51% stake in the biopharmaceutical company BioPartners Holdings (Switzerland). Although the transaction is still in the preliminary stages, the move signals Actavis’ interest in entering the biosimilars market. More...		  
 
Lonza to provide GSK with biopharm manufacturing
Lonza has agreed to support the ongoing development of GlaxoSmithKline’s biopharmaceutical pipeline by supplying manufacturing capacity for five early-stage monoclonal antibodies. More...		  
   
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Product Profile
Agilent
Automatic and reliable detection and quantification of low concentrated protein impurities down to 0.05% and below with the Agilent 2100 Bioanalyzer!

Read more...

Product Profile
Dishman
In the last few months Dishman Pharmaceuticals has successfully obtained the Certificate of suitability to the monographs of the European Pharmacopoeia (CEP) for the following Active Pharmaceutical Ingredients (API):

- Indapamide
- Bupivacaine HCl

Read more...

Product Profile
Kimberly-Clark
With the KIMTECH PURE* G3 Sterile STERLING* Nitrile Gloves, KIMBERLY-CLARK PROFESSIONAL* has introduced a low-cost sterile nitrile glove combining the sensitivity of latex with the protection of nitrile.

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Product Profile
Oxoid
Harmonized Culture Media for MLT
Oxoid and Remel, the world leading microbiology brands of Thermo Fisher Scientific, have introduced a complete portfolio of culture media for the microbiological examination of non sterile pharmaceutical products, as recommended in the Harmonized Microbial Limit Tests chapters in the Ph. Eur, USP and JP (current editions).

Read more...
 

Product Profile
Oxoid
Media Fill Trials
Oxoid Cold filterable Tryptone Soya Broth has been specially developed to meet the increasing regulatory demands of undertaking aseptic process validations (media fills). This highly filterable medium allows new guidelines to be met, and aseptic process simulations without the need for heating or changing filters

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Product Profile
Wockhardt
Thanks to expert staff, Wockhardt has become a leading global Pharmaceutical Contract Manufacturer. From development to high-volume commercial manufacture, we utilise more than 25 years of contract manufacturing experience to ensure your product is professionally managed all the way to market.

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Event Profile
9th Annual World Drug Manufacturing event profile:
November 30 – December 2 2010 Berlin, Germany
World Drug Manufacturing 2010 will debate the latest industry challenges occurring throughout small molecule and biologic manufacturing. The industry is facing increasing pressure to reduce costs, in order to remain competitive against generics. It is therefore more important than ever that companies reduce waste, streamline processes and increase their global presence.

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Event Profile
Vetter
Visit Vetter at booth 4E66 at the CPhI/ICSE 2010 for information on products and services from this specialist in the aseptic filling of drug-delivery systems.

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How do you normally hear about recalls of pharmaceutical products?
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■   Mainstream news outlets 23%
■   FDA alerts 39%
■   Word of mouth 9%
■   Other 5%

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