MHRA Inspection Prompts European Review Of US Firm's Drug Products
This article was originally published in The Gold Sheet
Executive Summary
Pharmaceutics International must suspend manufacturing of commercial and investigational medicinal products largely for failure to manage cross-contamination risks appropriately, according to EU GMP non-compliance notice. Resumption of IMP production will hinge on approval of trial-by-trial risk assessments.
You may also be interested in...
Enforcement Log, Dateline 09.30.16: Pan Drugs, Zhejiang Hisoar, Wockhardt, Zhejiang Bangli, Pharmaceutics International
Pan Drugs, Zhejiang Hisoar hit with data integrity warning letters; Wockhardt, Zhejiang Bangli and three others lose US market access; Pharmaceutics International's EU access in jeopardy.
Podcast: The Week In European Consumer Health Industry News, 8 March 2021
HBW editors Tom Gallen and David Ridley discuss the big issues in the European consumer health market from the past week. In this edition, they delve into probiotics, digital health and Bayer’s recent turnaround.
The Ins And Outs Of The EU's Approach To COVID-19 Vaccine Procurement & Exports
EU trade expert Hervé Jouanjean considers the reasoning behind the EU’s vaccine procurement approach and Italy's decision to block exports of AstraZeneca's COVID-19 vaccine.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: