23-Aug-2016 - Increased cost pressures and a shift to biologics manufacturing are driving demand for automation technologies, says Zenith which is opening two offices in the US.
22-Aug-2016 - An Indian facility owned by Pfizer’s Hospira unit has been banned from supplying some drugs to the EU after MHRA inspectors found breaches of manufacturing regulations.
22-Aug-2016 - Actavis has recalled five lots of a diabetes drug glipizide made by Patheon after tests revealed that the tablets did not meet specifications.
18-Aug-2016 - The US FDA wants to reclassify pharmaceutical co-crystals as solvates rather than intermediates to reduce the regulatory burden on manufacturers that work with them.
17-Aug-2016 - Pfizer supplier Zhejiang Medicine Co. should quiz staff to determine the extent of data integrity deficiencies at its API plant in Xinchang, China according to the US FDA.
17-Aug-2016 - An issue at a GSK API manufacturing site will limit supplies of the superbug busting antibiotic Avycaz for the next six months according to drug manufacturer Allergan.
15-Aug-2016 - Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.
11-Aug-2016 - Concerns raised by the US FDA pertaining to cGMP at a Florida facility are expected to be resolved within six months, according to Valeant.
10-Aug-2016 - Pfizer unit Hospira has recalled one lot of the anaesthetic made at its facility in Rocky Mount, North Carolina after particulate matter was found in a vial of the drug.
10-Aug-2016 - PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.
10-Aug-2016 - The US FDA has criticised Chinese manufacturer Concept Products for not fixing cGMP violations observed by inspectors who visited its manufacturing site in Tianjin.
09-Aug-2016 - Teva has recalled an injectable antibiotic that is one of only two products currently made at the Godollo, Hungary facility that was hit with a US import ban in May.
09-Aug-2016 - Bayer has recalled its injectable haemophilia drug Kogenate in Spain according to the country’s regulators.
09-Aug-2016 - The US FDA has identified quality problems at a Smithfield, Rhode Island plant where Alexion makes the immunosuppressant Soliris (eculizumab) and other products.
09-Aug-2016 - Pfizer has temporarily halted production at a former-Hospira aseptic plant in Chennai, India after regulators observed manufacturing issues during an inspection in June.
08-Aug-2016 - The High Court in Bangladesh has ordered 34 firms to stop making drugs and recall products after discovering they had ignored a ban imposed in June.
08-Aug-2016 - The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.
08-Aug-2016 - W.R. Grace has opened a pharma quality control laboratory at its manufacturing facility in Albany, Oregon and predicted higher drug intermediates sales in the second half of the year.
04-Aug-2016 - Several children have been hospitalized by a vitamin D supplement made by Inno Pharma according to regulators in Denmark.
04-Aug-2016 - The US National Institutes of Health (NIH) has permanently halted trial drug production at a site where cGMP violations were identified last year.
The International Conference of Harmonisation (ICH) guidance document on elemental impurities, Q3D, reached step 4 in December 2014, m...