Excipients, raw materials and intermediates

EMA places Zhejiang Huahai under ‘increased supervision’ over quality issues

17-Oct-2018 By Ben Hargreaves

The EMA has placed Zhejiang Huahai under supervision, after the firm produced valsartan medication contaminated by probable carcinogens.

eTheRNA guarantees mRNA supply with Belgian manufacturing site

11-Oct-2018 By Maggie Lynch

eTheRNA announced it will be opening a cGMP compliant mRNA manufacturing facility in Belgium, to increase production of its three mRNA encoding proteins.

CPhI Worldwide 2018

CPhI 2018: Dispatches from Madrid

11-Oct-2018 By Flora Southey

Following stints in Paris and Frankfurt, CPhI Worldwide has again set up in Madrid for three days of insight briefings, biopharmaceutical tracks and networking.

CPhI Worldwide 2018

Ashland launches film coating tech in response to ‘continuous' demand

09-Oct-2018 By Flora Southey

The Aquarius Genesis film coating system is specially designed for continuous manufacturing, but can also be applied to batch processes, says executive.

Continuous manufacturing: When will everyone be doing it?

05-Oct-2018 By Ben Hargreaves

The answer, according to consultant Emil Ciurczak, is in 10 years – at least, if generics manufacturers and CMOs want to be competitive.

Bosch to present oral solid dosage production device

03-Oct-2018 By Maggie Lynch

Bosch packaging technology will showcase its laboratory device for oral solid dosage forms, Xelum R&D for continuous manufacturing.

Cambrex cements North Carolina presence with buildings purchase

01-Oct-2018 By Maggie Lynch

Cambrex, a small molecule and API manufacturer, announced it will expand to establish a ‘center of excellence’ for process and development of its API clinical supply.

Evonik expands API and advanced intermediates manufacturing with €36m investment

26-Sep-2018 By Maggie Lynch

Evonik completed a €36m expansion of its contract manufacturing capabilities of API and advanced intermediates in the US and Europe.

EU-US mutual recognition extends with Portugal added to roster

24-Sep-2018 By Ben Hargreaves

With the US recognising Portugal’s ability to carry out GMP inspections, 15 countries are now part of the mutual recognition agreement between the EU and the US.

Chinese API producer refuses entry of EU inspectors

12-Sep-2018 By Ben Hargreaves

Jiangsu Yew Pharmaceutical outright refused permission for inspectors from Hungary to visit its site, resulting in the suspension of the company’s marketing authorisation.

UK gov’t guidance leaving too little time to adjust to ‘no deal’ Brexit?

10-Sep-2018 By Ben Hargreaves

IPT speaks to life sciences lawyer, Jane Summerfield, to interpret the recent guidance from the UK government in the event of a ‘no deal’ Brexit.

US FDA issues an alert on life-threatening porcine therapy API

07-Sep-2018 By Maggie Lynch

The FDA issued an alert that Sichuan Friendly Pharmaceuticals has recalled its porcine thyroid API.

Researchers target rapid changes to downstream continuous manufacturing

29-May-2018 By Nick Taylor

Academic research underpins many of the early success stories in continuous manufacturing. Now, Blair Brettmann and her team are working to write another chapter by applying electrospinning and other techniques to downstream processing.

INTERPHEX 2018

Excipient makers want to be the ‘first second’ in novel ingredient development, say execs

17-May-2018 By Flora Southey

An improved relationship between drugmakers and excipient suppliers could help drive development in the novel inactive ingredient sector, says industry expert.

Ardena continues M&A strategy with CMO buy

14-May-2018 By Flora Southey

CDMO Ardena has added drug product capabilities with the purchase of active pharmaceutical ingredient and excipient-focused Syntagon.