21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
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 .
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.
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.
16-Apr-2013 - Novasep has discovered that the drug manufacturing regent Togni II is highly explosive and as inflammable as gunpowder.
28-Mar-2013 - BD says a brand new facility and sustainable pricing will allow the company to compete as it enters the generics market following FDA approval of its first injectable drug.
27-Mar-2013 - As excipient suppliers are inundated with similar requests from users regarding quality and raw material sources, IPEC (International Pharmaceutical Excipients Council) is looking to streamline the exchange of information between the different companies.
14-Mar-2013 - Tokyo-based API Corporation, a unit of Mitsubishi Chemical Holdings Group, is making an investment in API and pharmaceutical manufacturer Neuland Laboratories’ facilities.
13-Mar-2013 - Catalent says it has acquired a Chinese softgel producer to expand its drug delivery offerings and expects more investments to come as part of a two-pronged plan into China.
12-Mar-2013 - Patheon says the shuttering of one of Banner’s manufacturing sites is necessary in integrating the recent acquisition into its global business structure.
11-Mar-2013 - Ashland says it is expanding its contract manufacturing business in order to offer its customers greater scope in drug solubilization.
06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.
05-Mar-2013 - SAFC will expand manufacturing capacity at its facility in Irvine, Scotland, to include large-scale production of bulk dry powder media and reagents to save EU clients’ money in shipment costs.
27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.
25-Feb-2013 - Bend Research has partnered with its second chemistry major in six months, teaming up with BASF to develop bioavailability-boosting excipients.
21-Feb-2013 - Capsugel says it will focus on lipid-based formulations as it launches a new Dosage Form Solutions Business Unit.
21-Feb-2013 - UK CMO Aesica claims its partnership with process innovation group Britest has already increased capacity without capital investment.