American Pharmaceutical News In Review

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March 07, 2023

Newsletter Sponsor

Innovative Softgel Technologies for Superior Drug Delivery
Sponsored by Catalent
As the innovator and global leader in softgel technologies, Catalent brings more than 85 years of development expertise and manufacturing experience to the full spectrum of lipid-based drug delivery. With an unparalleled track record of commercial success, softgel is a proven technology that solves complex formulation, solubility, bioavailability, and development challenges. With innovative softgel technologies, a global manufacturing network, and integrated supply solutions, Catalent can help bring molecules to market faster as optimal treatments for patients.

	Industry News

FDA Extends Review of BioMarin’s ROCTAVIAN Gene Therapy for Adults with Hemophilia
BioMarin Pharmaceutical Inc. announced that it received notice from the FDA that the agency has ... read more »

Sun Pharma Completes Acquisition of Concert Pharmaceuticals
Sun Pharmaceutical Industries Limited announced the successful completion of its acquisition of ... read more »

FDA Issues Guidance on Potency for mAbs and Therapeutic Proteins that Target Viruses
FDA has issued the draft guidance “Potency Assay Considerations for Monoclonal Antibodies and Other ... read more »

FDA Approves Intramuscular Administration for Merck’s MMRV Family of Vaccines
Merck announced that the FDA has approved the addition of the intramuscular (IM) route of ... read more »

	QC Corner

On-Demand Webinar: Ensure your Pipetting is QC Compliant
In this webinar, Joni Åke, Product Manager at Sartorius, and Axel Taube, Service Product Manager at ... read more »

	Infographic

Biopharmaceutical Characterization: Evaluation Criteria to Help You Choose the Right Partner
This infographic looks at a number of points to consider when choosing your contract research organization partner. read more »

	Featured Articles

		Cleaning, Disinfection and the Problems Caused by Chemical Residues Cleaning and disinfection are necessary protective and reactive steps to address microbial deposition on surfaces within pharmaceutical cleanrooms. An... read more »

		Establishing a Robust Quality System in a 503B Outsourcing Facility A sterile compounding pharmacy can elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic ... read more »

	Featured Video

On-Demand Webinar: Sterilization and Sterility Verification of Single Use Systems
In this live webinar, hear from Martell Winters & Adam Staples as they discuss the Sterilization and Sterility Verification of Single Use Systems. watch »

On-Demand Webinar: Lower Bioprocessing Costs and Time with Raman Spectroscopy
In this live webinar, hear from Dean Stuart as he talks about Lower Bioprocessing Costs and Time with Raman Spectroscopy watch »

	Featured Products

Labrafac™ MC60
Gattefossé Glyceryl mono and dicaprylocaprate NF / Glycerol monocaprylocaprate (Type I) EP learn more »

Compritol® 888 ATO
Gattefossé Glyceryl dibehenate NF / Glycerol dibehenate EP learn more »

CTech™ SoloVPE® System
Repligen With its patented variable pathlength technology, the SoloVPE System unlocks the power of Slope ... learn more »

	Featured Whitepaper

eBook: Improved Efficiency with Label-Free Biolayer-Interferometry
The articles in this publication provide an overview of BLI technology and its applications for pharmaceutical use. read more »

App Note: Preparation of Standards For Chromatographic Analysis
In analytical R&D or QA/QC laboratories, accurate standard preparation is crucial for the quality of the analytical results, which in turn has an enormous effect on laboratory efficiency. This ... read more »

	More Products

ADAPTA 100 Capsule Filler Learn More
Ascentis ES Cyano L10 HPLC Columns Learn More
Central Chiller Systems for Manufacturing Learn More

	Directory Categories

Automated Sample Dilution Equipment Search More

Pharmaceutical Inspection Search More

Pharmaceutical Excipients Search More

	Events

BIO International Convention
Boston, MA – 06/05/2023
Stand up for innovation. Stand up for truth. And stand up for science. It’s time to inspire, honor, and recognize the true value of the breakthrough ... event details »

ASMS Conference
Houston, Texas – 06/04/2023
71st ASMS Conference on Mass Spectrometry and Allied Topics event details »

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