American Pharmaceutical News In Review

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September 12, 2019

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	Industry News

Metrix Company Recalls Specific Lots of Empty IV Flexible Containers
The Metrix Company is recalling specific lots of the empty IV flexible containers due to potential ... read more »

Nevakar Completes Enrollment for NVK-002
Nevakar has completed enrollment for its Phase III CHAMP study, evaluating the ability of NVK-002 to... read more »

FDA Accepts Trevyent New Drug Application for Review
United Therapeutics announced the FDA has accepted for review the NDA for Trevyent® (treprostinil) ... read more »

FDA Confirms Omeros’ Schedule for Rolling Review of BLA for Narsoplimab
Omeros announced the FDA agreed with the company’s proposed schedule for the rolling review of the ... read more »

ANI Launches Vancomycin Hydrochloride for Oral Solution
ANI Pharmaceuticals announced the launch of Vancomycin HCl for Oral Solution, 250mg per 5mL (the ... read more »

Teva Canada Announces the Approval of HERZUMA
Teva Canada announces Health Canada has granted a NOC for HERZUMA® (trastuzumab), biosimilar to ... read more »

	Featured Articles

Microbiology Roundtable In general, what are some of the current critical issues/trends facing pharmaceutical manufacturers ... read more »

Major CMC Commercialization Gaps for Gene Therapy Products Manufactured for a Diverse Pediatric Subpopulation(s) The development of cell and gene therapy products to address serious and life-threatening conditions... read more »

	Featured Video

Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis
Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis read more »

Watch Webinar: Global Regulators’ FAQs on CMC in IND/BLA: Filing A Retrospective Look At Past Mycoplasma Validation Queries and Responses
Watch Webinar: Global Regulators’ FAQs on CMC in IND/BLA: Filing A Retrospective Look At Past Mycoplasma Validation Queries and Responses read more »

	Featured Products

MicraSpray MS 150
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Crodasol HS HP
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	Featured Whitepaper

Advanced Formulation and Testing Approaches for Pediatric Medicines and Higher Compliance in Children
The need for pediatric drugs has been widely recognized worldwide. read more »

Wall Chart: COMPLETE SOLUTIONS FOR COMPLETE CONFIDENCE with Steritest™ System
Our expertise in sterility testing dates back over 40 years from when we invented the original Steritest^™ closed filtration system, which changed sterility testing forever. We are raising the ... read more »

	Events

Stability Testing Summit
Boston, MA – 09/23/2019
Come to the Stability Testing Summit on September 23-24, at the Hyatt Regency Boston Harbor in Boston, Massachusetts. The time has never been more ... event details »

Pharmaceutical Manufacturing and Cleanroom Technology
London, UK – 10/08/2019
Addressing the Microbiological Aspects in Cleanroom Design and Engineering SMi Group are pleased to announce the Inaugural Pharmaceutical Cleanroom ... event details »

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