Archives for May 21, 2013

DISPATCHES FROM INTERPHEX

New DFS Unit Built on Technology, R&D and Manufacturing, says Capsugel

Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.

Impax Hires Specialists to Help Sort Manufacturing Issues

Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.

FDA Hits Boehringer-Ingelheim with Warning Letter for Particles, cGMP Violations

Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.

Aspen & Local CMOs to Benefit from GSK's Aus Packaging Plant Closure

GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.

Possible API Contamination at Chinese CMO Leads to Canadian Recalls

Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.

Bioartificial Liver Project Looks to Disposable Bioreactors for Large Scale Cultures

Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.