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.
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.
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.
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.
08-Jan-2015 - Hospira has recalled ten lots of injectable Mitoxantrone it says are subpotent and contain impurities.
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.
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.
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.
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.
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.
17-Dec-2014 - Big Pharma firms’ exposure to Russia’s volatile rouble is limited and planned manufacturing investments will go ahead according to observers.
17-Dec-2014 - The US FDA has set up a committee to provide advice on scientific, technical and medical issues concerning drug compounding.
17-Dec-2014 - The US FDA is now calling for prescribing information intended for health care professionals to be distributed electronically, with few exceptions.
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.
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.
10-Dec-2014 - The Competition Commission of India (CCI) has approved Sun Pharma’s $3.2bn acquisition of Ranbaxy.
09-Dec-2014 - Experts at CPHI India say companies failing manufacturing inspections need to be more honest with their data.
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.
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.
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.
Employing spectrophotometry and liquid chromatography quantitation of Ninhydrin-positive substances achieves 0.05% reporting sensitivi...
The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination...
Assessment of biosimilar molecules requires an orthogonal analytical approach. Any one particular analytical technique is not ab...