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Dispatches from CPhI 2015

Ex-FDA inspector: How to avoid 483 observations during your next facility audit

13-Oct-2015 - Want to pass an FDA inspection? Do not answer back, do not volunteer information and do not sign anything, says an ex-auditor and regulatory consultant.

Live coverage of CPhI

The plaza to be: Medicine manufacturers meet in Madrid

12-Oct-2015 -   [View the story "Meds makers meet in Madrid " on Storify]

US FDA issues alert for sterile products made by Californian compounder

06-Oct-2015 - The US FDA has issued a product safety alert and recommended a compounding pharmacy cease manufacturing operations after observing unsanitary conditions at a Californian facility.


UK and India sign agreement to help ensure drug quality

05-Oct-2015 - The MHRA has signed a Memorandum of Understanding (MOU) with Indian regulators to help ensure the quality of drugs in the UK.

US FDA withdraws approval for Sun migraine drug over concerns about Halol plant

28-Sep-2015 - The US FDA has revoked approval for Sun Pharmaceutical Industries’ extended-release epilepsy drug Elepsia XR over concerns the firm's manufacturing plant in Halol, India does not meet quality standards.

EC, EU and WHO share 'need to know' private drug data

23-Sep-2015 - European regulators and the WHO have begun sharing confidential information about drug applications, quality, and inspections under a new agreement.

A reliable supply chain has never been more important, says Mylan CEO

23-Sep-2015 - Drugmakers need more certainty and reliabilty around their supply chain in light of increased regulatory vigilance says Mylan, itself carrying out remediation across several Indian facilities.


Indian firm reconstructing API plant after being slapped with USFDA warning

16-Sep-2015 - Indian API maker Pan Drugs is reconstructing its manufacturing suite after holes in the wall and rusty equipment landed the facility a US FDA warning.

Illegal online pharmacies a source of fake drugs says Estonian regulators

16-Sep-2015 - Illegal internet pharmacies and a desire for cheaper meds mean fake drugs are a problem even in smaller pharmaceutical markets say Estonian regulators.

Black mould and rusty equipment lands Indian TB drug supplier WHO warning

04-Sep-2015 - An Indian TB drugmaker has been hit with a WHO Notice of Concern but an independent audit carried out by its customer Svizera Europe disputes the GMP violations raised.

Europe, US, Japan: The recall round-up

27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

News in brief

Merck recalls 276,000 pill bottles

20-Aug-2015 - Merck & Co. has recalled two chemotherapy products because of cracked caps, including one it manufactures for Novartis’ Sandoz.

Pharma plants strike in Pakistan to protest QC rule changes

19-Aug-2015 - Pakistani pharmaceutical manufacturers are today halting production in protest at changes to manufacturing regulations.

Three Mylan plants in India hit with FDA warning letter

19-Aug-2015 - As it tries to close its biggest deal ever -- a $33bn acquisition of Perrigo -- Mylan is now also dealing with an FDA warning letter citing cGMP violations tied to three of its manufacturing facilities in India.

Manufacturing alerts and issues at Teva, Pfizer, and more

18-Aug-2015 - Teva’s UK business has alerted the regulator that packets of the painkiller and anti-seizure medicine Pregabalin are printed with the wrong dosage.

EU lays out draft on new obligatory safety features for medicines

18-Aug-2015 - As part of European efforts to help stem the spread of counterfeit medicines, the European Commission has laid out the details of a key part of its Falsified Medicines Directive (FMD).

Excipient manufacturers raise concerns over stability testing

13-Aug-2015 - Manufacturers of excipients are being sent inappropriate requests for stability data by some regulators and pharma companies, threatening to disrupt the supply chain, IPEC claims.

News in brief

GSK plans to reopen contaminated NC site this weekend

13-Aug-2015 - The GSK site tainted with Legionella bacteria will likely reopen in a few days, the company says.

Legionella bacteria force GSK to temporarily close North Carolina plant

12-Aug-2015 - GlaxoSmithKline was forced to briefly shutter its Zebulon, NC, manufacturing facility after the company discovered legionella bacteria in one of its cooling towers.

House to FDA: who’s in charge of clinical trial manufacturing?

10-Aug-2015 - US politicians have given the NIH and FDA until Friday to answer questions about oversight at a contaminated National Institutes of Health clinical trial manufacturing site.

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