The QMN Weekly Bulletin

The FDA is not meeting its requirements to inspect high- and medium-risk domestic devicemakers every two years and faces challenges inspecting foreign establishments, according to a new government report.

The FDA takes issue with one of Novartis’ manufacturing facilities in a Jan. 24 warning letter citing the unit’s production and process controls for its human rabies vaccine RabAvert and bulk ingredient for diphtheria and tetanus toxoid concentrate, used in GlaxoSmithKline’s (GSK) combination vaccines Infanrix and Pediarix.

More clarity on how drug manufacturers may change production processes within a preapproved range without having to submit postapproval supplements is detailed in the FDA’s new draft guidance on the International Conference on Harmonisation (ICH) Q8 Guideline.

Alpharma Inc. agreed to sell its active pharmaceutical ingredients [API] unit to certain investment funds managed by 3i Group PLC for $395 million in cash.

The FDA — and American consumers — got another warning last week about the need for vigilant monitoring of imported drugs from the developing world, especially from China.

Chinese Pharmaceutical Company Shanghai Hualian, which is the sole supplier of abortion drug mifepristone in the U.S., has been accused of manufacturing contaminated leukemia drugs that are harming health of the patients.

“It might be Super Tuesday [in] the U.S. today but it is also a super Tuesday for Shannon,” said IDA chief executive Barry O’Leary as American medical device manufacturer Zimmer announced an investment of [$73 million] for the Shannon Free Zone that will create 250 new jobs over the next five years.

Cambridge Major Laboratories (CML) said it is planning to execute a $30m expansion project which will spawn one of most modern active pharmaceutical ingredient (API) manufacturing sites in North America.

NASDAQ-listed Albany Molecular Research Inc. (AMRI) has bought FineKem Laboratories, a manufacturing facility located in Aurangabad, India.