Pharmaceutical Technology ePT Weekly
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PharmTech
May 4, 2017
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In this issue:

EMA Begins Brexit Discussions

Catalent Increases Spray Drying Capacity

GSK Expands MD Manufacturing Site

Top Stories

FDA Warns 14 Companies for Sale of Fraudulent Cancer Treatments

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.
/ read more /


Fresenius Kabi Acquires Merck KGaA's Biosimilars Business and US-Based Akorn

With two acquisitions, German company Fresenius Kabi enters biosimilars market and expands in US.
/ read more /

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PODCAST

Jonathan Knight, vice-president of New Product Development at Cambrex Corp., discusses the environmentally friendly, economical process route that won CPhI's 2016 award for innovation in APIs and intermediates.

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Industry News

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.
/ read more /


EMA and EU Member States Begin Brexit Discussions

The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the UK's departure from the EU.
/ read more /


More Industry News

Supplier News

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.
/ read more /


Lonza's Bioscience Business “Soft” Due to Quality Issues

Lonza revealed it received a warning letter from FDA for its cell therapy manufacturing plant.
/ read more /


More Supplier News

Bio/Pharma News

GSK Expands Maryland Biopharma Manufacturing Site

GSK invests $139 million to expand production capacity for Benlysta (belimumab) in Rockville, MD.
/ read more /


FDA Approves Radius Health’s Tymlos to Treat Osteoporosis

The drug is approved to treat postmenopausal women with osteoporosis and is the first anabolic bone building agent approved in the US in approximately 15 years.
/ read more /


More Bio/Pharma News

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.
/ read more /


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.
/ read more /


More Regulatory News

FEATURED TOPICS

MANUFACTURING

Using Solar Energy for Process Heating

Renewable energy can improve energy efficiency and reduce carbon dioxide emissions in pharmaceutical manufacturing processes.
/ read more /

API SYNTHESIS & MANUFACTURING

PAT for Continuous API Manufacturing Progresses

Advances in process analytical technology have been achieved, but significant challenges remain.
/ read more /

STANDARDS & REGULATIONS

FDA Quality Metrics Initiative Challenges Manufacturers

Industry fears limited benefits as FDA readies voluntary data tracking program.
/ read more /

OUTSOURCING

Staffing for China's Rapidly Growing Biomanufacturing Industry

New study shows China biopharma companies face staffing shortages.
/ read more /


UPCOMING WEBCASTS

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


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


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

CPhI North America

May 16–18, 2017

Pharmaceutical Sciences World Congress

May 21–24, 2017

Excipientfest Asia

June 7–8, 2017

more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Click here /

More Reference Library

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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