American Pharmaceutical News In Review

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September 11, 2023

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	Industry News

Amneal Receives FDA Approval for Calcium Gluconate Injection
Amneal Pharmaceuticals announced it has received Abbreviated New Drug Application (ANDA) approval ... read more »

FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition
Genentech, a member of the Roche Group announced that the FDA accepted the company’s Biologics ... read more »

European Commission Expands Merck’s ERVEBO® Ebola Zaire Vaccine Indication to Include Children 1 Year of Age and Older
Merck announced that the European Commission (EC) has approved an expanded indication for ERVEBO for... read more »

FDA Issues Final Guidance on Human Factors Engineering Principles for Combination Products
The FDA issued the final guidance, Application of Human Factors Engineering Principles for ... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Infographic

Extractables and Leachables Testing for (Bio)Pharmaceuticals
This infographic breaks down some of the most important terms and definitions of the E&L process. Download this infographic to learn more. read more »

	Featured Articles

		Improving Gene Therapy Development with Organ-on-a-Chip Technology Topics covered in this guide include applications for gene therapy, challenges faced in developing gene therapies, how Organ-on-a-Chip technology can ... read more »

		New Regulation to Reduce Contamination Risks in Sterile Manufacturing—and Ways to Adapt Both PDA TR 90 and the European Union’s recently revised GMP Annex 1 require manufacturers of sterile pharmaceuticals to implement and document a ... read more »

	Featured Video

On-Demand Webinar: Overcoming Business Challenges with Alternative Microbiology Methods
In this informative webinar, attendees will have the opportunity to learn valuable insights on how to navigate the challenges commonly encountered ... watch »

On-Demand Webinar: Boosting Biomanufacturing: Design or Upgrade to More Efficient Facilities
This webinar covers Integrated Solutions one-of-a-kind capabilities and introduces the Discover® Program with case studies. watch »

	Featured Products

Lasair Pro
Particle Measuring Systems The Lasair Pro supports a complete contamination control solution including clean area monitoring (... learn more »

MiniCapt® Remote Microbial Air Sampler
Particle Measuring Systems Ideally suited for aseptic environments as part of a facility monitoring system, the MiniCapt® ... learn more »

Aquarius™ TF Film Coating System
Ashland Inc. Aquarius™ TF film coating system provides superior opacity, brightness and aesthetics to tablets ... learn more »

	Featured Whitepaper

Targeted Amplicon Sequencing Case Study: Discover Bacterial Biodiversity Water Profiling
Microbial profiling is an essential process control step in many manufacturing, fermentation, and bioremediation workflows. Specific microbes are necessary for different applications, and tracking ... read more »

Article: Optimizing monoclonal antibody development and manufacturing with next- generation media and feed systems
Streamlining monoclonal antibody (mAb) manufacturing workflows relies on optimization at every stage of the process, from initial bench-scale development through to commercial manufacturing. This ... read more »

	More Products

1260 Infinity II Multi-Method System Learn More
BENCHTOP Manifold Freeze Dryer Learn More
TPW Tablet Processing Workstation Learn More

	Directory Categories

Analytical Instrumentation Search More

Pharmaceutical Excipients Search More

Pharmaceutical Chiller Systems Search More

	Events

Global Bioprocessing Summit
Berlin, Germany – 11/16/2023
The industry, professionals, and scientists are actively seeking methods to delineate more precise guidelines and anticipated requirements for ... event details »

Bio-IT World Conference & Expo Europe
London, England – 11/29/2023
Bio-IT World Conference & Expo Europe unites a community of leading life sciences, pharmaceutical, clinical, healthcare, informatics, and technology ... event details »

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