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QA/QC

News headlines

Fresenius Kabi NY aseptic plant upgraded by USFDA

15-Jan-2015 - A Fresenius Kabi plant in New York has been upgraded, and up to five new products could receive FDA approval, almost three years after receiving a warning letter.

update

US FDA rejects Pharmexcil claims it no longer lets Indian regulators know about inspections

14-Jan-2015 - The US FDA has rejected Pharmexcil claims it no longer informs Indian regulators of manufacturing plant inspections and said its policy is to invite host-country inspectors to attend visits.

FDA blocks Australia site from importing tainted Cialis as Lilly claims innocence

12-Jan-2015 - The US FDA has published an import alert for an Australian manufacturing site of Eli Lilly after the agency found that its Cialis pills were tainted with the active ingredient of another popular ED (erectile dysfunction) drug -- Pfizer’s Viagra. 

US FDA approves Impax’s Parkinson’s disease treatment following resolved manufacturing issues

12-Jan-2015 - Almost two years since it was first rejected , Impax Pharmaceuticals said late last week that the US FDA has approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease.

After Warning Letter, a recall for Hospira injectables

08-Jan-2015 - Hospira has recalled ten lots of injectable Mitoxantrone it says are subpotent and contain impurities.

Italian Medicines Agency withdraws GMP certificate from Indian manufacturer

06-Jan-2015 - The agency issued a warning letter  and withdrew the GMP (Good Manufacturing Practice) certificate from Hyderabad, India-based Sri Krishna Pharmaceuticals for 10 GMP deviations found during an inspection at its Nacharam granulation plant in December.

China-based paracetamol maker hit with US FDA warning letter

06-Jan-2015 - Novacyl Wuxi Pharmaceutical has received a US FDA warning letter for failing to investigate the origin of metal particles found in drugs made at its paracetamol plant in China.

Not prepared for track & trace? US FDA grants amnesty until May

05-Jan-2015 - The US FDA will give drugmakers and distributors until May to comply with new track and trace laws in order to minimise disruptions in the supply chain.

API supplier issues again cause FDA to reject Pozen drug candidates

18-Dec-2014 - For the second time the US FDA has rejected two versions of Pozen’s investigational drug candidate because of issues with a supplier’s foreign manufacturing facility.

News in brief

US FDA issues Form 483 to Hovione API facility in Portugal

18-Dec-2014 - The US FDA’s pre-approval inspection at Hovione’s API plant in Loures, Portugal, covering two NDA filings, resulted in a Form 483 with three inspectional observations. 

Rouble trouble: Big Pharma exposure to Russian currency volatility limited

17-Dec-2014 - Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.

Compound interest? US FDA sets up compounding pharmacy advisory committee

17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.

US FDA calls for prescribing info to be distributed electronically

17-Dec-2014 - The US FDA is now calling for prescribing information intended for health care professionals to be distributed electronically, with few exceptions.

IPEC-Americas aims to make drug excipient users TUPP aware

15-Dec-2014 - Manufacturers should profile the "black specks" created during excipient production and share details with customers according to guidance finalised by IPEC-Americas, which says the unavoidable particles are starting to earn drugmakers 483s.

From CPHI India

IPA says bad inspectors making Indian manufacturers fear visits

11-Dec-2014 - The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.

Sun closes in on Ranbaxy deal with CCI approval

10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.

From CPHI India

CPHI India: experts say ‘data fraud’ dragging down Indian manufacturing

09-Dec-2014 - Experts at CPHI India say companies failing manufacturing inspections need to be more honest with their data.

From CPHI India

Eager-to-please Indian manufacturers creating GMP chaos says expert

08-Dec-2014 - Cultural differences and broken promises are behind Indian GMP failures and acute generics shortages in the UK, according to one pharmaceutical distributor.

FDA to allow paper or electronic transaction info transfers under DSCSA

08-Dec-2014 - New draft guidance from the US FDA related to track-and-trace legislation facilitates the transfer of both paper and electronic accounts of transaction info, history and statements for manufacturers, repackagers and wholesale distributors.

Flu vaccine underwent 35 QA/QC tests in Italy death probe, says Novartis

05-Dec-2014 - Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.

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