All news articles for October 2017

US FDA bans APIs made by Fleming Labs

news in brief

US FDA bans APIs made by Fleming Labs

By Gareth Macdonald

Fleming Laboratories has been banned from shipping APIs to the US by the FDA which says its manufacturing plant in Nawabpet, Telangana in India is not up to code.

GettyImages/Waldemarus

BIOPRODUCTION CONGRESS DUBLIN 2017

HPRA tells drug makers how to get ‘GMP inspection-ready’

By Flora Southey

Firms should identify risks prior to inspection, make staff available during regulator visits, and respond promptly post-inspection when undergoing GMP site checks, says Ireland’s Health Products Regulatory Authority (HPRA).

Gettyimages/Ruskpp

MHRA pulls Evertogen's GMP certificate after inspection

By Gareth Macdonald

Evertogen Life Sciences Limited should recall drugs made at its facility in Mahabubnagar, India according to the MHRA, which identified critical quality and data integrity problems during an audit in August.

FYI: The latest trends in APIs, FDFs and CMOs at CPhI

CPhI Worldwide 2017

FYI: The latest trends in APIs, FDFs and CMOs at CPhI

By Flora Southey & Dan Stanton

The pharma world has converged in Frankfurt, Germany for this year’s CPhI Worldwide. In-Pharmatechnologist is here too to report the latest trends affecting the industry.

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