09.09.2010Looking back, moving forward - The fine chemical industry has gone through a few difficult periods in the last decennium. More recently, however, the market has improved quite a bit. In this article, we will have a look at the top 10 companies in the fine chemical market. In order to be able to put things in the right perspective it is interesting to look at the situation in the early 2000s first.
more09.09.2010Inventing The Future - The modern tablet development usually includes three basic formulation techniques - direct compression, dry compaction and wet granulation. Depending on the API, characteristics and the desired dosage, one of these formulation approaches is used. Direct compression is the most preferable method due to the low development costs, simple solvent free procedure and a much shorter time-to-market compared to the other methods. Disadvantages of this technique are powder flow difficulties, segregation, poor content uniformity and lubricant sensitivity.
more09.09.2010Forgotten Regulation - Walking in the footsteps of Reach the 2008 EU Classification, Labeling and Packaging (CLP) Regulation (Regulation (EC) 1272/2008) has received less attention than it deserves from authorities, supply chains and senior management, who are still trying to cope with the massive resource and business implications of Reach. Andrew Fasey explains why despite the pain, businesses stand to gain from putting in place comprehensive compliance strategies for the EU regulation on classification, labeling and packaging of substances and mixtures (CLP).
more09.09.2010Hard to Copy - Market data shows that sales of biotech products are worth billions of dollars worldwide - just the sort of prospect that normally brings generic manufacturers rushing in to take advantage. Usually, patent expiry is followed by a flood of low cost generics that lead to prices falling by 80-90%, but this has not happened yet with biological products. Why not?
It is partly due to the great complexity of the products and the difficulties in copying them accurately. In addition, Europe has set high regulatory standards for proving equivalence and the U.S.
more09.09.2010Exchanging Information - The first deadline for Reach registration is approaching fast. This process requires that future registrants work together in Substance Information Exchange Forums (SIEF) in order to submit one joint registration dossier for one substance. In its efforts to make this registration process a success, Mercedes Viñas, manager of chemical regulation at Cefic, along with the Cefic SIEF working group have developed recommendations and tips in order to allow SIEFs to deliver.
more09.09.2010Paradigm Shift - Europe's chemical industry is working hard to implement Reach, and the first phase of registration will draw to a close at the end of November. Despite this deadline, globally active companies cannot afford to lose sight of the fact that numerous other jurisdictions are currently making changes to pertinent legislation, too.
more09.09.2010Preparation - The next milestone in Reach is coming up: the 2010 deadline. So what are the hurdles in completing registration, and what happens if it doesn't go to plan?
2010 Deadline
more09.09.2010New Start - Major changes are impacting the pharmaceutical industry: the financial crisis, hard hitting government finances and health care budgets throughout the world, as well as patent cliff effects exacerbated by inadequate R&D productivity levels. Traditional business models applied by the pharmaceutical industry are being undermined, forcing change within the sector that also could spell out sweeping implications from the pharma CMO sector.
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