Duragesic Patches to Change Colour to Prevent Accidents
The US FDA says it requires a colour change of the painkiller patch Duragesic in order to reduce injury and death caused by accidental exposure.
Archives for September 23, 2013
PTI 'Polishes-Up' Tablet Dedusting with Pharmaflex 750
Pharma Technology Inc. (PTI) says its new deduster offers tablet manufacturers more flexibility with greater residual powder being removed due to its polymer spiral.
Consent decree halts operations of Ohio drug manufacturer
A federal judge in the Southern District of Ohio has approved a US FDA consent decree against Shamrock Medical Solutions for drug manufacturing and labeling violations.
Pfizer, GSK, Sanofi, Others Take Issue with FDA’s CMO Draft Guidance
Pfizer, GlaxoSmithKline, Sanofi, and at least ten other big pharma companies, CMOs and industry groups are criticizing aspects of the recent FDA draft guidance governing quality agreements.
Agila slammed with US FDA warning: 'Visible holes' in gloves
The use of "flaking" and non-sterile gloves in aseptic processing, as well as cGMP violations, has led to the the US FDA issuing a warning letter to Agila for its Bangalore, India plant.
Molecular Profiles to Formulate Psoriasis Drug in Multi-Firm Project
Molecular Profiles has been chosen to develop topical and solid dose formulations of a preclinical psoriasis treatment as part of a multicompany conglomerate led by Telormedix.
Generic companies seek help from service providers to avert revenue crises
The panic behind the patent cliff for big pharma is now hitting generic companies, which are increasingly turning to service providers and consultants to help find solutions for holes in their pipelines.
EU Nod for AZ's Nasal Flu Vaccine For Children
AstraZeneca has received positive opinion from the EU for use of its nasal spray vaccine Fluenz Tetra in children.