American Pharmaceutical News In Review

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November 09, 2016

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Connected at Every Level

A lot of people in the CDMO industry claim they offer end-to-end service. What gets in the way is a lack of program management – support that the industry is asking for. Alcami is the first to actually make this happen – a unified solution for customers across various technologies.

	Industry News

Emmaus' NDA for Sickle Cell Disease Accepted for Review by FDA

Mallinckrodt Announces FDA Approval of OFIRMEV® IV Bag Presentation

Mylan and Biocon Announce FDA Submission for Proposed Biosimilar Trastuzumab

FDA Approves Roche's VENTANA ALK (D5F3) CDx Assay for use on the VENTANA BenchMark ULTRA System

Upsher-Smith Expands Generic Product Portfolio

Endo Strengthens Leadership Team with Appointment of Two Executives

	Featured Articles

Acceleration of Process Characterization Activities to Streamline Program Timelines Acceleration of Process Characterization Activities to Streamline Program Timelines In an increasingly competitive landscape for the launch of new biopharmaceutical products, there ... read more »

Analysis of Two Active Pharmaceutical Ingredients (API) Products Using UV Spectrophotometry with Multi-Component Analysis and a Fiber Optic Dissolution Analyzer Analysis of Two Active Pharmaceutical Ingredients (API) Products Using UV Spectrophotometry with Multi-Component Analysis and a Fiber Optic Dissolution Analyzer UV Spectrophotometry has traditionally been a simpler and less time and labor consuming method for ... read more »

	Featured Video

Webinar: Getting the Most out of Your Standard Curve
Webinar: Getting the Most out of Your Standard Curve
The first part of this webinar will outline controls that a laboratory should consider to assure consistency in standard curves and thereby increase ... read more »

Webinar: API in Capsule: A Smart Approach for Rapid Drug Development
Webinar: API in Capsule: A Smart Approach for Rapid Drug Development
Micro-dosing is the procedure of dispensing precise amounts of drug substance into capsules (powder-in-capsule or PIC). The PIC approach can help on ... read more »

	Featured Products

BioTrak® Real-Time Viable Particle Counter
read more »

	Featured Whitepaper

40 Tips to Improve your Sterility Process
40 Tips to Improve your Sterility Process
MilliporeSigma has over 40 years of experience developing products for sterility testing. We have applied this expertise to provide you with a library of sterility testing tips. Register today to get ... read more »

Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for Elemental Impurities in December 2014. Regulators are now implementing the requirements worldwide. The U.S. ... read more »

	Events

IFPAC®-2017
North Bethesda, Maryland (Washington, D.C.) U.S.A. – 02/27/2017
Advanced Manufacturing Science… Emerging Technologies to Modernize Pharmaceutical/Biopharmaceutical Development and Manufacturing IFPAC is the ... event details »

DCAT Week ‘17
New York, NY – 03/20/2017
DCAT Week is the premier business development event for companies engaged in and supporting pharmaceutical development and manufacturing. Its unique ... event details »

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