USP revision aids PET drug prep
A proposal by the U.S. Pharmacopeial Convention aims for greater flexibility in the preparation of radiopharmaceuticals for use in positron emission tomography. The USP has proposed quality assurance revisions to the general chapter for production and compounding.
The revision covers PET drugs for human administration, and among its goals is easing production requirements for drugs used in research. It complies with state-regulated pharmacy compounding practices and other regulatory requirements. And it mirrors the FDA’s final PET GMP rule and guidance.
USP notes that PET drugs have come a long way since the original monograph was written in 1989. Drivers for the revision include the greater number of PET drugs, higher production levels, shorter synthesis and QC times and more complex synthesis processes.
According to USP, the revision will ensure that drug identity, strength, quality and purity are uncompromised.
Growth of Generics Industry Remains Upbeat in Canada
As per our latest research report “Generic Drug Market in Canada”, the Canadian generics industry is anticipated to show healthy growth rates in coming years and is projected to witness a CAGR growth of around 14% during 2009-2013. Future of the industry remains promising owing to higher margins and lower competition in Canada compared to other big markets. We have found that the growth in the generics industry will be mainly driven by ageing population, patent expiry of several blockbuster drugs, and the government support in the form of cost containment. Besides, high participation in industry activities by the market players, higher margins to pharmacists, and effective developmental efforts
Our research indicates that presently the share of generic drugs in Canada is about one-fourth of the overall pharmaceutical market. Besides, many foreign firms are looking forward to invest in the Canadian generics industry. Some key therapy areas such as, chronic disease, hypertension, and diabetes represent big opportunity for generic drug manufacturers in Canada. We have also evaluated various factors that will propel the growth of generics market in Canada during the forecast period (2011-2013).
The report “Generic Drug Market in Canada” is a complete source of knowledge and analysis regarding the Canadian generic drugs sector with complete emphasis on data reliability and authentication. The report has covered every important aspect of the generic drug market and elaborated significant proportion of the current market trends along with their future outcome. Sections like, ‘generics market performance’ and ‘regulatory environment’ provides an in-depth market analysis and key activities by the government respectively. These sections measure industry in terms of key statistics and current regulatory mechanisms that have a major impact on current revenue patterns and future growth.
The report is an outcome of an in-depth research and prudent analysis of the Canadian generic sector with effective presentation and forecasting in key areas. The forecasting in report relies on suitable methods and techniques that further enhance reliability in future projection. Moreover, the major activities and description of market players have been elucidated in the report.