American Pharmaceutical News In Review

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July 25, 2019

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New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis

Over-the-counter (OTC) medication is used by almost every individual from teething infants to our oldest citizens. The high utilization rate of these medications makes managing the quality of OTC products a crucial part of the pharmaceutical manufacturing process.

	Industry News

Lipocine Receives FDA Clearance for Testing of NASH Candidate
Lipocine has received clearance from the FDA to clinically investigate LPCN 1144 in an expanded ... read more »

Regulus Therapeutics Announces RGLS4326 Program Hold
After review of the requested submission, FDA notified the Company of additional nonclinical data ... read more »

Jubilant Cadista Issues Recall of Drospirenone, Ethinyl Estradiol Tablets
Jubilant Cadista Pharmaceuticals is voluntarily recalling one lot of Drospirenone and Ethinyl ... read more »

FDA Advises Patients Not to Use Herbal Doctor Remedies’ Medicines
FDA advises patients not to use any drugs manufactured by Herbal Doctor Remedies, Monterey Park, ... read more »

Immix Receives FDA Authorization to Expand Clinical Trial
Immix Biopharma announced it received a letter from the FDA authorizing it to proceed with expanding... read more »

Samus Therapeutics Launches PU-AD Clinical Program in Alzheimer's Disease
Samus Therapeutics announced the initiation of its clinical program for PU-AD, an oral, brain ... read more »

	Featured Articles

Environmental Monitoring Program for Aseptic Vaccine Products This article is primarily about the Environmental Monitoring (EM) program that should be in place ... read more »

An Interview with Catalent One of the major technical challenges is the delivery of poorlysoluble drugs. read more »

	Featured Video

Watch Video: Sartorius Stedim Biotech Tour
Sartorius Stedim Biotech Tour read more »

On-Demand Webinar: Beyond Bioprocessing 4.0
In this webinar, you'll learn about market trends, business drivers, and key enablers to drive Bioprocessing 4.0. read more »

	Featured Products

i-Series Integrated HPLC Systems
read more »

Pegasus GC-HRT High Resolution TOFMS
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	Featured Whitepaper

Benefits of 2D-LC/MS/MS in Pharmaceutical Bioanalytics
This application demonstrates the 2D-LC/MS/MS analysis of cell supernatants from an in vitro cell suspension-based assay. Superior separation by 2D-LC allowed the analysis of 16 target metabolites ... read more »

Is Your Quality Agreement Fit-for-Purpose?
A commitment to quality is essential to deliver safe, effective products that solve serious health issues and have a remarkable impact on people’s lives. read more »

	Events

CPhI Korea
South Korea – 08/21/2019
CPhI Korea provides a dynamic meeting place for a wide range of industry suppliers to engage with purchasers and decision makers from the ... event details »

SMi’s 10th Annual Biosimilars Conference
London, UK – 09/24/2019
SMi Group are delighted to announce the 10th annual Biosimilars Conference taking place on 25th and 26th September 2019. This year’s event will be our... event details »

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