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American Pharmaceutical News In Review
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February 26, 2024
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  White Paper: FDA 483s and Non-Compliance in Pharma

The United States Food and Drug Administration (FDA) has the authority to inspect pharmaceutical companies that manufacture FDA-regulated products at any time, and write down their observations on Form FDA 483, commonly abbreviated to “483”. Form 483s are very important to FDA-regulated companies, regardless of how many, if any, they have received. A single 483 tells a company exactly which areas to improve - or to correct - to remain compliant (and therefore operational). Download this white paper to learn more about FDA 483’s, drug production, compliance and QC.

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» Industry News
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  Alvotech Accepts Offer for Sale of Shares at Approximately $166 Million at Cost Basis of $16.41 per Share
Alvotech, a global biotech company specializing in the development and manufacture of biosimilar ... read more »
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  Alvotech and Teva Announce US Approval of SIMLANDI® Injection, the First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira®
Alvotech and Teva Pharmaceuticals announced that the FDA approved SIMLANDI (adalimumab-ryvk) ... read more »
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  Rigel Pharmaceuticals Acquires U.S. Rights to GAVRETO
Rigel Pharmaceuticals announced that it has entered into a definitive agreement to acquire the U.S. ... read more »
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  United States Pharmaceuticals Market Size to Surpass $1 Trillion by 2030
CoherentMI published a report, titled, United States Pharmaceuticals Market was valued at US$ 599.47... read more »

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» QC Corner
QC Corner
  QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature
The Environmental Monitoring program is an important quality control for the pharmaceutical ... read more »

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» Infographic
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  Eight Benefits of Switching to Digital Pharmaceutical Production
This infographic covers the reasons and benefits of transitioning from paper-based processes to a digital manufacturing production process. read more »
» Featured Articles
EVENT   No Big-Bang Moment: An AI-Supported Future in Pharma Will Take Time
The life sciences industry is right to be optimistic about the potential of generative AI. Biotech startups are already testing AI-generated drugs in ... read more »
EVENT   Pharmaceutical Industry Litigation Funding: What You Should Know
Litigation related to pharmaceutical and biotechnological products is not uncommon. The attorney’s fees and costs associated with this litigation are ... read more »
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» Featured Video
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  On-Demand Webinar: Reducing Candidate Risk and Achieving Development Success with a Robust Developability Assessment Tool
In this on-demand webinar, we explore how DEVELOPICK™ systematically screens molecules, identifying candidates with the best potential for progression... watch »
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  On-Demand Webinar: Transforming Nanoparticles by Continuous Manufacturing
In this on-demand webinar: hear from Diant Pharma's CEO Antonio Costa, PhD as he discusses Transforming Nanoparticles by Continuous Manufacturing. watch »

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» Featured Products
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  VIVACOAT® A - Ready-to-Use Coating System
JRS Pharma VIVACOAT® is a ready-to-use fully formulated coating system for pharmaceutical and nutritional ... learn more »
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  Polyplasdone™ Plus Multifunctional Disintegrant
Ashland Inc. Polyplasdone™ Plus multifunctional disintegrant is a direct compression superdisintegrant containing... learn more »
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  BIOne 250 Bioprocess Controller
Distek, Inc. The BIOne 250 Bioprocess Controller combines advanced functionality with cost-effectiveness, making ... learn more »

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» Featured Whitepaper
EVENT   Whitepaper: Automating the Endotoxin Testing Workflow
Pharmaceutical quality control (QC) testing labs face growing endotoxin testing demand and, consequently, relentless business pressure to enhance lab productivity. However, cumbersome and error-prone ... read more »
EVENT   Article: Establishing a Robust Quality System in a 503B Outsourcing Facility
The transition from being a sterile compounding pharmacy to an outsourcing facility is challenging. This review article is directed towards 503B outsourcing facilities strengthening their quality ... read more »

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» More Products
FlexAct Configurable Bioprocess Solution Learn More
Pharmaceutical Manufacturing and Drug Development Services Learn More
SWELSTAR Pregelatinized Starch NF WB-1(Wet binder) Learn More
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» Directory Categories
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Pharmaceutical Membrane Filtration Systems Search More
Pharmaceutical Software Search More
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| Events
EVENT
  IFPAC-2024
Washington, D.C. –  03/03/2024
Join industry leaders, regulators, researchers, and solution providers from across the globe for in-depth discussions on the latest trends, ...
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EVENT
  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, ...
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