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  Pharmaceutical Technology Europe E-Alert
 
14 May 2010
IN THIS ISSUE
EMA criticized
Price cuts in Spain
API quality agreement
USP revises guideline
 
EMA criticized over transparency rules
The European Ombudsman has recommended that the European Medicines Agency (EMA) review its refusal to grant public access to reports on adverse drug reactions. More...
 
Spain urged to double generic prescriptions
In response to stringent price cuts introduced in Spain, the European Generics Association (EGA) is urging the Spanish government to adopt mechanisms that will help increase the dispensing of generic medicines. More...
 
SOCMA issues API quality agreement template
In an effort to standardize quality agreements for APIs, a template to help manufacturers and customers comply with US regulatory requirements has been developed by an affiliate of SOCMA. More...
 
USP widens door for pending monographs to excipients
The US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary monograph. More...
 
Join PTE on LinkedIn!
Join Pharmaceutical Technology Europe's group on LinkedIn. More...

Product Profile
Elan
Elan Drug Technologies, the world’s leading drug delivery business, develops and manufactures innovative pharmaceuticals using their extensive experience and proprietary drug technologies in partnership with pharmaceutical companies. Read more...

Product Profile
Hamamatsu
Hamamatsu introduces a new imaging based plate reader, the FDSS/µCELL; an easy to use, fast and cost-effective solution for compound screening and
assay development in the Pharmaceutical and Biotech Industries.
Read more...

Product Profile
Shimadzu
LC-20AP - a new preparative HPLC pump

Shimadzu introduces the next generation LC-20AP Preparative LC pump, suitable for analytical, semi-prep and prep LC applications without changing pump heads. Read more...

Event profile
Grace Davison
Grace Davison Discovery Sciences at Forum Labo 2010
Grace Davison Discovery Sciences™ are pleased to be able to showcase their latest products on stand G100-H101 at the Forum Labo & Biotech exhibition being held in Hall 4 at Paris Expo, Porte de Versailles, from 1st to 4th June 2010. Read more...

Event profile
CPhI China
China events - CPhI, ICSE, P-MEC and BioPh

Continued double digit growth in the Chinese pharmaceutical industry is reflected in record visitor pre-registration levels and a sell-out of exhibition space at this year’s UBM International Media Read more...

Event profile
Total Processing & Packaging
Featuring Interphex, Total Processing & Packaging is the UK’s flagship exhibition for processing & packaging. With over 500 exhibitors from 30 countries, there are a wealth of pharma manufacturing solutions on display. Read more...

Key Topic Updates
Latest blog posts
Does the calculus of Big Pharma’s emerging market growth strategies add up?
Biopharmaceutical boom and bust
ExcipientFest Soundbites
More blog posts

Latest articles
Do emerging markets provide the answer to the pharmaceutical industry?
Obtaining simultaneous multiple dissolution profiles of solid oral dosage formulations
Change is in the air for the European Clinical Trials Directive
More latest articles

May events
PABME & PHARMA 2010 (23–25 May | United Arab Emirates)
Total Processing & Packaging 2010 (25–27 May | UK)
Healthcare Packaging Conference & Workshops (26–27 May | USA)
More events

Key Topic Updates

Survey
During tablet manufacture, what is the most common problem encountered by your company?
  Poor weight uniformity 12%
  Poor content uniformity 15%
  Poor formulation design 34%
  Inadequate equipment maintenance 14%
  Incorrect equipment operation 15%
  Other 10%

This week we would like to know...

To encourage innovation in excipients, do you think FDA should review novel excipients outside of a new drug application?
Click here to vote

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