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15 July 2014

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IN THIS ISSUE
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Featured Topics

Trends in Manufacturing and Equipment PharmTech's annual equipment and manufacturing survey shows gains in process analytical technology and indicates areas for future innovation. More...

Industry Seeks Clearer Standards for Track and Trace Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain. More...

Health Systems Raise the Bar on Reimbursing New Drugs As payers refuse to cover new drugs, CMOs take a hit. More...

Top Stories
EMA Recommends 39 Drugs in First Half of 2014 The European Medicine Agency details the agency's recommendations for drug-marketing authorizations for the first half of 2014. More...

Baxter Issues Recall Due to Particulate Matter Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter. More...

Dissolution Problems Spur Three Recalls Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues. More...

Hospira Issues Recall Due to Mold Contamination Puncture in container and overwrap cause leak in intravenous solution, leading to recall by Hospira. More...

Biotech Industry Forms International Council New International Council on Biotechnology Associations advocates biotechnology growth. More...

FDA Publishes Guidance on ANDA Submissions FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements. More...

Novartis Personalized Cell Therapy Receives FDA Breakthrough Therapy Designation FDA grants breakthrough therapy designation to Novartis chimeric antigen receptor therapy. More...

FDA Approves Drug for Non-Hodgkin Lymphoma The FDA approved Beleodaq for the treatment of patients with peripheral T-cell lymphoma. More...

Industry News

Glatt and Innopharma Labs Partner on Real-Time In-Line Particle Characterization for Batch and Continuous Production Glatt and Innopharma Labs have formed a partnership to provide Glatt's customers access to Innopharma Labs' non-invasive, real-time 3D particle characterizer, Eyecon, which has the ability to generate live particle size and shape information. More...

Hospira Acquires Orchid's API Manufacturing and R&D Facilities Hospira acquires assets from Orchid Chemicals & Pharmaceuticals for $218 million. More...

Catalent Marks 40 Years in Japan with New Investments and Country Leader Catalent appoints a new country leader and expands facilities. More...

Webcasts
Analytical Challenges and Case Studies in Method Development for Fixed-Dose Combinations Thursday July 17, 2014 at 11:00 AM EDT Sponsored by: Patheon

Optimizing Bioavailability: Enhancing Pharmaceutical Productivity On Demand Sponsored by: BASF and Catalent Pharma Solutions

Keys to Regulatory Compliance in the Pharmaceutical Supply Chain On Demand Sponsored by: Aptean

More Webcasts

Products/Services Profiles

Colder Products Company

Make sterile connections faster, easier and safer with genderless connectors
Simplify single-use systems with AseptiQuik^® genderless connectors from CPC. Innovative design eliminates separate male and female components to reduce system complexity and inventory requirements, while increasing process flexibility. Read more

Merck Millipore

Merck Millipore celebrates 40 years of first class sterility testing solutions
In 1974, Merck Millipore was the first to market a closed filtration device: Steritest™. Since this time, through dedicated research & development, we have been instrumental in raising the industry’s standards – reducing the risk of false positive and negative results, increasing reliability and improving workflow for microbiologists around the world. Read more

Nitritex Ltd

Nitritex Ltd is a leading manufacturer of an extensive range of high quality cleanroom consumables, marketed under the BioClean™ brand. Products include gloves, goggles, masks and garments designed for critical environments where product and process protection is paramount. Read more

Shimadzu

The Nexera MP UHPLC for LC/MS analysis in drug detection processes
Shimadzu’s Nexera MP UHPLC Front End system for LC/MS is perfect for LC/MS analysis conducted in pharmacokinetics and synthesis stages in drug detection processes. Read more

Bioprocessing and Sterile Manufacturing
View technical articles on the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and more.

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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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