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March 04, 2019

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	Industry News

FDA Warns CanaRx for selling Unapproved, Misbranded and Unsafe Imported Drugs
The FDA posted a warning letter to CanaRx for facilitating the distribution of unapproved new drugs ... read more »

Novo Nordisk Files for Label Update for Fiasp
Novo Nordisk announced it recently submitted label updates to the EMA and the FDA for Fiasp® 100 u/... read more »

BioMarin Receives Positive CHMP Opinion in Europe for Palynziq
BioMarin announced the CHMP has adopted a positive opinion for the company's MAA for Palynziq® ... read more »

Halozyme Announces FDA Approval of Herceptin Hylecta
Halozyme Therapeutics announced Genentech has received approval from the FDA for Herceptin Hylecta™,... read more »

Lonza Completes Divestment of Water Care Business
Lonza announced the completion of the divestment of its former Water Care business and operations to... read more »

American Regent Announces the Re-Introduction of Aminocaproic Acid Injection, USP
American Regent announced the re-introduction of Aminocaproic Acid Injection, USP, a therapeutically... read more »

	Featured Articles

Assessing Aluminum Vaccine Adjuvant Filling, Sedimentation, and Resuspension in Sealed Vials using Water Proton NMR The filling level, sedimentation, and resuspension of aluminum adjuvants (alum) in sealed vials can ... read more »

Does the International Council for Harmonization Offer a Solution via ICH Q12? The world economies are increasingly threatened by barriers to trade, while the pharmaceutical ... read more »

	Featured Video

Watch Video: Successful Cleaning Validation with the Sievers TOC Analyzer
Sievers* total organic carbon (TOC) analyzers provide accurate and reliable measurements for a wide range of applications, including water system ... read more »

Watch Video: Glass Breakage Bench Tip
In a recent poll US drug makers told American Pharmaceutical Review they would like to learn more about glass breakage in relation to primary ... read more »

	Featured Products

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
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Accucore Solid Core Columns
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	Featured Whitepaper

Transformative Shifts in Vacuum Decay Leak Testing
Vacuum decay is a test method that has been proven over decades and improved with new technology innovations. read more »

The Use of Advanced pH, Time or Microbial-Dependent Oral Drug Delivery Technologies for Precise Release in the Colon
The colon has emerged as an optimal site for the oral delivery of drugs targeting inflammatory bowel diseases (IBDs) including Ulcerative Colitis (UC), Crohn’s disease (CD), Amebiosis or colonic ... read more »

	Events

ExL’s Proactive GCP Compliance
Philadelphia, PA – 03/18/2019
Now in its tenth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum for both senior-level clinical quality and ... event details »

CPhI Japan
Big Sight Centre in Tokyo – 03/18/2019
Gathering 20,000+ pharma professionals from 65+ countries worldwide, CPhI Japan is the ideal business platform for international pharma professionals ... event details »

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