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Grunenthal says anti-crush tech Endo uses for Opana ER helps prevent abuse

25-Aug-2016 - Grunenthal has reiterated the benefits of its anti-crush intac tech after licensee Endo withdrew its request to have Opana ER labelled as “abuse deterrent."

API firm Unimark Remedies warned by US FDA about Indian plants

25-Aug-2016 - The US FDA has warned API manufacturer Unimark Remedies about unsanitary conditions at its facility in Vapi and Bavla in India.

update - Hospira regrets non-compliance

Pfizer unit Hospira and Napp broke APBI code during Remsima push

24-Aug-2016 - Pfizer’s Hospira unit and Napp Pharmaceuticals broke ABPI rules covering the promotion of biosimilar medicines according to the UK industry group.

CMO contracts will transfer to Pfizer

Pfizer to buy AstraZeneca's antibiotic business in deal worth up to $1.5bn

24-Aug-2016 - Pfizer will buy most of AstraZeneca’s antibiotics business in a $1.5bn (€1.32bn) deal that will see the Anglo-Swedish drug firm continue to package Merrem at its Macclesfield, UK plant for at least the next 18 months.

Pharma pollution an 'ignored' cause of antibiotic resistance

24-Aug-2016 - Pollution in pharma supply chains is contributing to the spread of antimicrobial resistance (AMR), says a new report.

Sagent recalls second lot of antibiotic made by Astral SteriTech after rust found in vial

23-Aug-2016 - Sagent Pharmaceuticals has recalled another lot of its injectable penicillin in the US after a customer found rust in a vial of the drug.

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.

EMA says biologics developers need to be extra vigilant

19-Aug-2016 - Biologics developers need to be more vigilant about immunogenicity and manufacturing changes than small molecule drug manufacturers according to the EMA.

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.

Statin APIs from Gedeon Richter-linked firm should be prohibited say GMP inspectors

16-Aug-2016 - German regulators want statin APIs made by Artemis Biotech to be banned after finding deviations good manufacturing practice (GMP) at the firm’s facility in Hyderabad, India.

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.

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.

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