16-May-2013 - The US House Energy & Commerce Committee on Wednesday advanced a bill to further secure the US prescription drug supply chain, though it stops short of mandating unit-level, electronic tracking and tracing of drugs.
15-May-2013 - Differences in elemental impurity standards being developed separately by the US Pharmacopeia and ICH could mean costly reformulations according to a pharmaceutical, API and excipient industry coalition.
08-May-2013 - The EMA may recommend new daily exposure limits for some phthalates as animal data have shown they can cause negative reproductive and development effects, according to a new draft guideline .
07-May-2013 - Pfizer has begun selling Viagra online in order to counter the trade in fake versions of its erectile dysfunction drug.
07-May-2013 - In a rare move, the FDA has publically released Alexion Pharmaceuticals’ response to a Form 483 following inspection of its US site and the discovery of microbial contamination.
06-May-2013 - A push to root out antimalarial counterfeit drugs in Ghana will begin later this year or early 2014 as part of a pilot project to test an FDA-developed counterfeit detector.
06-May-2013 - Manufacturing problems and costs associated with a new device-focused strategy hurt in Q1, but Hospira says efforts to fix troubled Rocky Mount facility are still on track.
06-May-2013 - Revised excipient guidelines expected from Brazilian regulator Anvisa this year will reduce confusion and further align standards with those in the US and EU says an industry expert.
02-May-2013 - As the USP, ICH and US FDA all aim to tackle elemental impurities testing for pharmaceuticals and excipients, questions still remain on whether the manufacturers will be able to comply with the looming requirements.
02-May-2013 - China’s implementation of GMPs for excipient manufacturers, as well as a developing US FDA-style DMF system, have added another layer of safety requirements but challenges remain for the regulators in ensuring compliance, experts say.
23-Apr-2013 - Pharmaceutical conferences are like buses - to paraphrase an old British joke - you wait for one and then three come along at once.
23-Apr-2013 - The FDA has finalised guidance on the manufacturing of antibiotics in order to prevent cross-contamination of finished pharmaceuticals and APIs with non-penicillin beta-lactam drugs.
22-Apr-2013 - The inventor of a reagent recently found to be highly explosive says many drug production chemicals may have similar profiles and that knowing how to handle them is the key.
22-Apr-2013 - The EMA’s upgrade to the EudraGMDP database aims to increase the safety of the EU supply chain by releasing GMP certificates and other data so companies can ensure supplier compliance.
17-Apr-2013 - Biostar Pharmaceuticals has blamed end-of-year losses on last year’s chromium-tainted gelatin scandal though it is slowly recovering following a suspension of sales enforced by the SFDA.
15-Apr-2013 - The US FDA has opened for public comment a new ICH draft guideline that aims to help manufacturers identify and control mutagenic impurities during the development of new drugs.
11-Apr-2013 - The US drought of the TB treatment isoniazid may soon ease after some manufacturers on the US FDA drug shortage list resume supply, but rationing looks set to continue for now.
10-Apr-2013 - Pfizer’s recall of Levoxyl has created a stink among manufacturers of the oxygen-absorbing canisters designed to stop such drugs degrading.
10-Apr-2013 - The manufacturing sites of Alexion Pharmaceuticals and Italy-based Wyeth Lederle S.p.A were cited in FDA warning letters for cGMP (current good manufacturing practice) violations in their production of APIs and finished pharmaceuticals, respectively.
09-Apr-2013 - India’s Directorate General of Foreign Trade (DGFT) has pushed back the deadline again for adopting new barcodes to track pharmaceutical exports by one year.