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Drug industry disaster concerns prompted lab expansion says Intertek

30-May-2017 - Drug industry concerns about natural disasters are driving demand for ‘storage-only’ stability testing according to Intertek, which has announced plans to expand its UK lab.

US ban for Changzhou Jintan Qianyao raises questions about customers says expert

24-May-2017 - The US FDA has banned APIs made by Changzhou Jintan Qianyao Pharmaceutical Raw Materials after staff told inspectors their quality testing plans were “in their heads.”

US FDA warns liquid drug firms to test for Burkholderia cepacia

23-May-2017 - Burkholderia cepacia contamination is a risk for drug makers according to the US FDA, which says only rigorous testing can ensure the safety of non-sterile, water-based products.

France's ANSM raises GMP concerns at Brazilian aseptic plant

17-May-2017 - Nova DFL’s dental adrenaline product has been denied marketing authorisation after French regulators raised seven critical deficiencies at its facility in Brazil.

AB Science suspends French masitinib trials after ANSM finds deviations

15-May-2017 - AB Science SA has halted French trials of its Ph III drug candidate masitinib after regulators uncovered good clinical practice (GCP) and pharmacovigilance deviations in an earlier study.

Trump needs to back bioscience to boost US drug making say experts

11-May-2017 - President Donald Trump should foster biotech investment if he wants more US-made pharmaceuticals say experts who argue that cutting regulations to attract small molecule drug manufacturers will only have a limited effect.

Italian regulators find problems at Kores' API plant in Roha

10-May-2017 - Italian regulators say Kores Limited’s facility in Roha, India should be banned from supplying the API ambroxol hydrochloride to the EU and advised users to find an alternative source.

US FDA sends Biocon Bangalore plant 483 with 8 observations

10-May-2017 - Issues in the quality testing of drug substance and product were among eight observations cited in a Form 483 following an inspection at Biocon’s site last month.

Vikshara says plant banned by US FDA has stopped making APIs

10-May-2017 - The US FDA has accused Vikshara Trading & Investments Ltd. of giving false statements about a strike to delay the inspection of an Ahmedabad API plant later found to be non-compliant.

US FDA warns Indian API maker for faking certificates of analysis

03-May-2017 - Falsified certificates of analysis (COA) and misbranding violations have landed Indian API maker Sal Pharma a US FDA warning letter.

Dr Reddy's: No production halt at Bachupally plant hit with Form 483

02-May-2017 - The US FDA has identified problems at Dr Reddy’s generic drug manufacturing site in Bachupally, India according to a filing on the Bombay Stock Exchange (BSE).

BPI Europe 2017

Roche on excipient inconsistencies: ‘Don’t blame suppliers, work with them’

02-May-2017 - An inconsistent lot of excipient Poloxamer 188 cut biologic yield 30%, but working with supplier BASF was key to prevent future problems, according to Roche.

Management’s management of quality still a problem say MHRA inspectors

26-Apr-2017 - The UK MHRA saw an increase in sterility issues at drug plants in 2016 although quality system problems remained the most common deficiency seen during inspections.

update

US FDA warns Lonza about Walkersville site

25-Apr-2017 - The US FDA has warned Lonza about operations at its facility in Walkersville, Maryland, raising concerns about validation and aseptic process simulations.

DSM Sinochem to up capacity at Delft antibiotic intermediates plant

24-Apr-2017 - DSM Sinochem (DSP) has announced its intention to increase antibiotic production capacity at its facility in Delft, the Netherlands.

Samsung Bioepis to take on J&J with FDA approved Remicade biosimilar

24-Apr-2017 - Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.

1st Stem Cell Community day in Germany

For stem cells 'the process is the product,' says Pluristem

19-Apr-2017 - Manufacturing tweaks have severe effects on the quality and yield of stem cells, says Pluristem which has successfully scaled-up production through a decade of process development evolution.

US ban for levonorgestrel supplier Qinhuangdao Zizhu raises WHO concerns

19-Apr-2017 - Discovery of data problems at Qinhuangdao Zizhu’s Hebei API plant indicates the firm did not follow a remediation plan agreed after a prequalification inspection in 2015 according to the WHO.

update

Teva confirms US FDA warning letter for Hangzhou, China API plant

18-Apr-2017 - Teva Pharmaceutical Industries says the US FDA has raised concerns about its API plant in Hangzhou, China.

US FDA criticizes quality systems at Mylan NV's Nashik plant

12-Apr-2017 - The US FDA has criticized quality systems at Mylan’s HIV drug plant in Nashik in Maharashtra, India. 

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