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Cost pressures turning pharma towards automation tech, says Zenith

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.

UK MHRA strips Pfizer-owned India antibiotics plant of GMP certificate

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.

Actavis pulls Patheon-made diabetes pills after out-of-spec tests

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.

US FDA wants to reclassify co-crystals to ease regulatory burden

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.

Pfizer vancomycin supplier Zhejiang Medicine warned by US FDA

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.

Problem at UK API plant not Italian site says GSK

GSK API "issue" will limit supplies of Allergan's superbug buster Avycaz

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.

AEMPS says Alcor's plan to fix problems at Spain plant is insufficient

15-Aug-2016 - Laboratorios Alcor SL's plan to fix problems at a manufacturing facility in Guadalajara, Spain is insufficient according to Spanish regulators.

Valeant gives six months timeline for FL plant reinspection after eye drug CRL

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.

Pfizer recalls anaesthetic made at Hospira's Rocky Mount facility

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.

PharmaTech expands recall of drugs made at Florida plant linked to B. cepacia outbreak

10-Aug-2016 - PharmaTech LLC has recalled more drugs made at the Florida plant that was linked an outbreak of B. cepacia last month.

News in brief

US FDA warns Concept Products for failing to fix cGMP violations at Tianjin plant

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.

Amikacin recalled by Teva after US shortage ends

Teva recalls injectable antibiotic in US over contamination concerns

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.

Bayer recalls Kogenate lots in Spain after out of spec stability results

09-Aug-2016 - Bayer has recalled its injectable haemophilia drug Kogenate in Spain according to the country’s regulators.

update

US FDA raises concerns about Alexion's Rhode Island Soliris facility

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.

Pfizer halts production at Hospira India plant slammed by regulators

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.

News in brief

Bangladesh Court orders 34 drug firms to halt production, again

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.

Third strike for Wockhardt as API facility hit with US import alert

08-Aug-2016 - The US FDA has banned products from a third Indian manufacturing plant operated by Wockhardt.

WR Grace opens pharma-focused QC lab and predicts second half intemediates growth

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.

Danish children hospitalized by super strength Inno Pharma vitamin D

04-Aug-2016 - Several children have been hospitalized by a vitamin D supplement made by Inno Pharma according to regulators in Denmark.

US NIH permanently halts drug production at site criticised by US FDA

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.

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