American Pharmaceutical News In Review

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April 24, 2024

Newsletter Sponsor

White Paper: Container Closure Requirements: Preparing for Updates to USP 382, 661.1, and 661.2

The landscape of pharmaceutical manufacturing and quality control is seeing a key change with crucial updates to the United States Pharmacopeia (USP) standards for container closure systems. This article will give a comprehensive overview of the evolving container closure requirements for parenteral products and insightful exploration of the alterations introduced by USP <661.1>, <661.2>, and, <382> equipping pharmaceutical manufacturers with the essential knowledge to navigate the evolving regulatory compliance standards effectively. Download now to learn more.

	Industry News

Vaccines Market Worth $94.9 Billion
The vaccines market in terms of revenue was estimated to be worth $78.0 billion in 2024 and is ... read more »

Endo, Inc. Completes Acquisition of Endo International plc's Assets
Endo, Inc., a newly formed entity, announced that it has completed the previously announced ... read more »

Harness Therapeutics Appoints Seasoned Biopharmaceutical Leader, Ms. Meenu Chhabra Karson, as Board Chair
Harness Therapeutics, a biotechnology company focused on protein upregulation to develop next ... read more »

Rilzabrutinib LUNA 3 Phase 3 Study Met Primary Endpoint in Immune Thrombocytopenia
Positive results from the LUNA 3 phase 3 study demonstrated that rilzabrutinib 400 mg twice daily ... read more »

	QC Corner

QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature
QC Corner: Environmental Monitoring: expert discussion on the benefits of a single incubation ... read more »

	Infographic

Pharmaceutical Solid-State Characterization and Crystallization within the Product Lifecycle
This infographic covers five essential considerations for solid-state characterization. read more »

	Featured Articles

		Applying Rigor to Regulatory Information Management Procurement As data standards compliance becomes increasingly stringent and as digital transformation ambitions expand beyond the Regulatory remit to encompass ... read more »

		Improving Drug Solubility and Solving Bioavailability Challenges by Leveraging Predictive Modeling and Simulation Tools The pharmaceutical landscape is quickly evolving as new technologies propel innovation across the clinical supply chain. Machine learning-powered (ML)... read more »

	Featured Video

Live Webinar: Achieving EU GMP Annex 1 Compliance: Monitoring Compressed Gases for Microbial and Particle Contamination
In this Webinar you will learn the requirements for monitoring of particles and microorganisms in controlled cleanroom environments. watch »

Live Webinar: Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
In this webinar, hear from Shiri Hechter from Nelson Labs as she will cover the testing of high-risk drug components for Diethylene Glycol and ... watch »

	Featured Products

S-125 Fully-Automatic Capsule Sealing Machine
Qualicaps As a pioneer in capsule manufacturing, Qualicaps has accumulated a wealth of know-how and ... learn more »

PURELAB® Chorus 1 Complete Ultrapure Water System
ELGA LabWater | Veolia One complete solution for the laboratoryPURELAB® Chorus 1 Complete provides a complete solution from... learn more »

EZ-Accu Shot™ Growth Promotion Test
Microbiologics Growth Promotion Testing of culture media can be a resource-consuming and tedious task. ... learn more »

	Featured Whitepaper

Whitepaper: Are Nitrosamines a Concern for Biologic Manufacturers?
The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered at risk. This article provides an ... read more »

Whitepaper: Changing Regulatory Environment for Nitrosamine Impurities
Regulatory agencies worldwide, including the European Medicines Agency (EMA) and US Federal Drug Administration (FDA), released guidance documents outlining risk-based approaches for detecting and ... read more »

	More Products

The AccuPyc II 1340 Gas Displacement Density Analyzer Learn More
Adept 4 Binary Gradient High Pressure LC System Learn More
CFS 1500 C Liquid Filling and Sealing Machine Learn More

	Directory Categories

Pharmaceutical Tablet Press Machines Search More

Pharmaceutical Liquid Filling Machines and Equipment Search More

Pharmaceutical Excipients Search More

	Events

CPHI North America
Pennsylvania Convention Center – 05/07/2024
The growing US pharma event is back in Philadelphia for May 2024 Don’t miss out on turning connections into endless opportunity. Learn, innovate, and... event details »

Excipient World Conference & Expo
Florida, USA – 05/13/2024
Excipient World is the only U.S. event focused exclusively on excipients. Join professionals from pharmaceutical, biologics, veterinary medicine, ... event details »

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