30-Oct-2014 - India has relaxed stability data requirements for API manufacturers seeking “written confirmation of quality” certificates needed to ship to the EU.
30-Oct-2014 - Novo Nordisk on Wednesday announced plans to hire up to 90 people at its newly-acquired manufacturing facility in West Lebanon, New Hampshire.
29-Oct-2014 - The European Directorate for the Quality of Medicines & Health Care, under the European Pharmacopeia, has set a new policy for the testing of bacterial endotoxins.
28-Oct-2014 - A plant being set up by Pharma Action and meat supplier Toennies will produce 15 tonnes of 100% traceable crude heparin a year.
27-Oct-2014 - A superbug-fuelled resurgence of polymyxin antibiotics has prompted the European Medicines Agency (EMA) to re-examine safety warnings for the side effect heavy anti-infectives
27-Oct-2014 - Novo Nordisk has been served with a subpoena over alleged manufacturing issues at its site in Kalundborg, Denmark.
23-Oct-2014 - Drugmakers’ clashes with regulators over the suitability of API starting materials suggest ICH Q11 is open to interpretation and that clarification is needed according to the EMA.
21-Oct-2014 - Generic drugmakers want biotherapeutic products to have general recommendations in the European Pharmacopoeia rather than individual monographs.
21-Oct-2014 - Patients receiving court-ordered treatment can be stopped from secretly spitting out their medicines by formulations which dissolve quickly in the mouth.
21-Oct-2014 - Venom from a Brazilian Wandering Spider that ‘wandered’ into a UK household’s shopping basket could treat erectile dysfunction, according to scientists, in one example of drug ingredients being sourced from nature.
20-Oct-2014 - Analysts predicting a second wave of global API hubs say it will be hard for manufacturers in Latin America, Ukraine and Taiwan to avoid the pitfalls that stymied former high growth sectors in Asia.
20-Oct-2014 - Over forty “necessary products” made at Apotex and IPCA facilities hit with an import alert can be sold in Canada after regulators took steps to prevent shortages.
20-Oct-2014 - Eli Lilly is set to close one of its Puerto Rican facilities as patent expirations and a shifting portfolio reduce its need for capacity.
16-Oct-2014 - Government contracts guaranteeing market share in Brazil are starting to attract innovators like Roche, Novartis and Sanofi and may see API suppliers get long-term work according to a spokesman for Sao Bernardo do Campo-based drugmaker, EMS.
15-Oct-2014 - Drug active ingredients in food supplements are Europe’s real falsified medicines problem according to the head of AIFA’s counterfeit prevention team.
13-Oct-2014 - The pharmaceutical industry must change its ingredients and manufacturing methods to cash in on the enormous purchasing power of European Muslims, says an expert.
09-Oct-2014 - The phrase “lean manufacturing” conjures up job cuts and not much more for many people, but managers can use the method to drastically simplify HPAPI (highly potent active pharmaceutical ingredients) production, says an expert.
08-Oct-2014 - The sharing of audit reports for active pharmaceutical ingredients (APIs) is essential in order to help avert the global decline in quality, according to Hovione’s CEO.
07-Oct-2014 - Counterfeit drugs and collaboration will be key topics for the EDQM say delegates at the organisation's 50th anniversary conference on Monday.
07-Oct-2014 - Lonza has launched an API-making platform that uses chemical microreaction technology for continuous processing.
Formulating a sugar-free syrup being at the same time stable and with a pleasant taste can be a real challenge. LYCASIN®, a liquid mal...