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American Pharmaceutical News In Review
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September 13, 2021
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  Why Extractables and Leachables Matter

Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy. When that balance is disturbed by issues such as product adulteration, the damage to patients, revenues and corporate reputation can be substantial.

That is why the pharmaceutical and medtech industries, along with their associated regulators, are paying increasing attention to testing requirements for extractables and leachables (E&L).


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» Industry News
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  Recall of One Lot of Firvanq by Azurity Pharmaceuticals
Azurity Pharmaceuticals is recalling one lot of Firvanq (vancomycin hydrochloride for oral solution)... read more »
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  Sanofi to Acquire Kadmon
Sanofi has entered into a definitive merger agreement with Kadmon Holdings, Inc. (NASDAQ: KDMN) a ... read more »
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  FDA Accepts of BLA for Tislelizumab in Esophageal Squamous Cell Carcinoma
BeiGene, a global, science-driven biotechnology company focused on developing innovative and ... read more »
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  FDA Declined Humanigen’s EUA Request for Lenzilumab in Hospitalized COVID-19 Patients
Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune ... read more »

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» Featured Articles
Laser-Induced Breakdown Spectroscopy of Pharmaceutical Products
Analytical methods that can determine the quality of pharmaceutical products fast and without the need for sample preparation are highly desirable. ... read more »
Message from the Editor: A Crisis In Pain Management
Let’s start off with some facts from the National Institute of Drug Abuse - Roughly 21 to 29 percent of patients prescribed opioids for chronic pain ... read more »
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» Featured Video
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  On-Demand Webinar: Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of ... watch »
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  On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

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» Featured Products
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  Nano DSC Complete Autosampler System v2
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» Featured Whitepaper
eBook: The Benefits of Employing FTIR, RAMAN and NIR Spectroscopy in Your Lab
Many of today’s plastics are multi component systems with multiple constituents like different polymers, fillers, plasticizers and compatibilizers. read more »

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| Events
EVENT
  Pre-filled Syringes San Francisco 2021
San Francisco, CA –  09/13/2021
As part of SMi’s leading Injectables series, this year’s event will address the key drivers of the pre-filled syringes and combination products ...
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EVENT
  SMi’s Aseptic Processing Conference
London, UK –  09/20/2021
The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic ...
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