PharmTech Europe, Weekly Alert
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PharmTech Europe

1 December 2015

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Top Stories

GMP Challenges for Advanced Therapy Medicinal Products

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
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Emerging Markets—An Opportunity for Pharma to Drive Sustainable Growth

Innovation and technology will be important differentiators for companies trying to drive sustained growth in emerging markets.
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FOCUS ON APIs

Advances in Heterocyclic Chemistry for API Synthesis

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.
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FDA Approves Ash Stevens as API Manufacturer for Takeda’s Multiple Myeloma Drug

Ash Stevens has received FDA’s approval to manufacture Takeda’s multiple myeloma drug, ixazomib, at its facility in Riverview, Michigan.
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MORE ON APIs

FOCUS ON EXCIPIENTS

Croda's French Facility Receives EXCiPACT Certification

Croda Choques SAS has become the company's third excipient manufacturing site, and the 24th such site worldwide, to receive certification.
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IPEC-America Suggests Improvements to FDA’s Inactive Ingredients Database

Representatives of the excipients industry responded to FDA’s request with new ways to make the IID more relevant and useful.
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More on Excipients
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NEWS AND TRENDS

Novo Nordisk to Switch to Renewable Energy by 2020

The goal is to have all of Novo Nordisk’s production plants operating on renewable electricity with zero CO2 emissions by 2020.
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Almac Expands Pharmaceutical Development Capacity

Almac is investing GBP16 million to expand its formulation and analytical development services.
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Modernizing Oral Solid-Dosage Manufacturing

Experts at the ISPE annual meeting describe best practices, including containment and production in classified spaces.
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Why Training Matters

Investing in worker training is crucial to the success of a company. This article reviews the benefits of a robust training program in pharmaceutical bulk manufacturing.
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More News

FEATURED TOPICS

BIO/PHARMA NEWS

Hikma Sells Ben Venue Manufacturing Facilities to Xellia

Xellia will acquire substantial parts of the Ben Venue site, including four sterile injectable manufacturing plants, which are not currently operational.
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REGULATORY NEWS

FDA Seeks Industry Support for Quality Metrics

FDA emphasizes the surveillance aspects of quality metrics to concerned drug manufacturers.
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MANUFACTURING

Better Days for Parenterals?

Although shortages, quality, and regulatory challenges remain, improved technologies and new investments suggest that the worst may be over.
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INDUSTRY NEWS

KTN Launches UK Medicines Manufacturing Landscape Portal

The platform was developed to address confusion about medicines manufacturing activities in the UK.
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SUPPLIER NEWS

Romaco Acquires Medipac AB and Extends Position in  Effervescent Tablets Sector

With the acquisition of Medipac’s tube filling assets for effervescent tablets, Romaco can now offer the complete line configurations for effervescent tablets.
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FORMULATION

Fixed-Dose Combinations

The advantages of FDCs are well recognized but their formulation and manufacture can be a challenge, Stefania Barzanti from IMA Active explains why.
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Webcasts

Addressing Formulation Needs With a Different Technology: Say "Hello" to Ion Exchange Resins

On Demand

Ion exchange resins have long been in the formulator’s toolkit, but only recently have they been used as excipients. Learn the value and benefits ion exchange resins bring to drug formulation challenges such as taste masking, abuse deterrence, controlled release, and more.
Sponsored by Dow


Stability Assessment for Shipment of API and Drug Products

On Demand
Increasing requests from regulatory agencies have focused on evaluation of APIs and drug products during shipment. However, little guidance has been provided on how to address these concerns. This webinar will address these questions and explore approaches to assessing stability of biologic APIs and small molecule drug products throughout shipment.
Sponsored by Patheon


more webcasts

Events

Analytical Procedures and Methods Validation

8–10 December 2015 | Philadelphia, PA, US

Stability Testing

8–10 December 2015 | Philadelphia, PA, US


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 Library

eBOOKS

Solid Dosage and Excipients 2015 eBook

This eBook examines how advances in technology, equipment, excipients, analytical techniques, software, and manufacturing practices are facilitating the development, scale up, manufacturing, efficacy, and delivery of solid- and semi-solid dosage forms.

more ebooks
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