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PharmTech Europe
2 May 2017

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Top Stories

Pharma Execs Compose Open Letter on EMA Relocation

The letter requests EMA announce its plans to relocate as early as June 2017.
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EMA Stresses Importance of Immunization

European Immunization Week promotes the use of vaccines to prevent disease.
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Hospira Recalls One Lot of 25% Dextrose Injection

The company is recalling one lot of 25% Dextrose injection after particulate matter was found within an internal sample syringe.
/ read more /

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Industry News

Growth of Japanese Pharma Market Driven by Biologics and Generic Drugs, Says CPhI Report

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.
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NIH Study Shows Antidepressants May Enhance Drug Delivery to Brain

A new NIH study in rats shows that the antidepressant amitriptyline combined with drugs to treat central nervous system diseases may enhance drug delivery to the brain.
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Regulatory News

Teva Cited for Process Control Failures

FDA sent a warning letter to Teva Pharmaceutical and Chemical (Hangzhou) Co. Ltd. after an inspection found the company failed to monitor and control quality.
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Phenobarbital Recalled Due to Labeling Error

Truxton, Inc. is voluntarily recalling one lot of Phenobarbital Tablets, USP, 15 mg because of a labeling error on declared strength.
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Bio/Pharma News

Amgen Asks Court to Weigh in on Dupixent, Claims Infringement

Amgen asked a judge to issue a judgment of infringement involving Sanofi/Regeneron's drug Dupixent and its use of a mechanism described in Amgen's '487 patent.
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Sanofi Hits Mylan with Anti-Trust Lawsuit

Sanofi filed an antitrust lawsuit with a district court in New Jersey alleging Mylan took steps to restrict access to a competing epinephrine autoinjector.
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Supplier News

DSM Sinochem Pharmaceuticals Boosts Manufacturing Capacity

DSM Sinochem will expand production of 7-ADCA at its Delft facility to support growth in sustainable antibiotics.
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Catalent Increases Spray Drying Capacity at San Diego Facility

The company increased capabilities at its Pharmatek San Diego facility in response to market demand for solubility enhancement solutions.
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FEATURED TOPICS

FORMULATION

Designing Optimized Formulations

Design of experiment plays a crucial role in the optimization process of formulation development.
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QUALITY

FDA Quality Metrics Initiative Challenges Manufacturers

Industry fears limited benefits as FDA readies voluntary data tracking program.
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API SYNTHESIS & MANUFACTURING

PAT for Continuous API Manufacturing Progresses

Advances in process analytical technology have been achieved, but significant challenges remain.
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FACILITIES

Using Solar Energy for Process Heating

Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
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Event Profile

Chemspec Europe 2017

International Exhibition for Fine and Speciality Chemicals
Date: 31st May to 1st June 2017
Venue: Munich Trade Fair Centre, Germany
Chemspec Europe is the international exhibition for fine and speciality chemicals. Known for its focused profile, Chemspec Europe is the place to be for international experts of the fine, custom and speciality chemicals industry.
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UPCOMING WEBCASTS

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Implementing Pharmaceutical Elemental Impurity Sample Preparation and Analysis
Live Webcast: Wednesday, May 10 at 11:00am EDT
Register now



Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
Live Webcast: Wednesday, May 24 at 11:00am EDT and Wednesday, May 31 at 11:00am CEST
Register now


ON DEMAND WEBCAST

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Understanding Pharmaceutical Elemental Impurity Regulations and Laboratory Considerations
On Demand
Learn more


Events

Interpack 2017

Dusseldorf, Germany

4–10 May 2017

OSD Continuous Manufacturing in the Current Regulatory Landscape

Floriana, Malta

8–9 May 2017

CPhI North Amercia

Philadelphia, United States

16–18 May 2017


more events

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 /


More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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