03-Oct-2011 - The Australian TGA is considering adopting EMA guidance on residual solvents, genotoxic impurities and other GMP topics.
29-Sep-2011 - The US FDA has filed a permanent injunction against a US drugmaker and sent a warning letter to a Chinese API producer following cGMP problems.
28-Sep-2011 - Lonza may build a stem cell production facility dedicated to manufacturing Mesoblast products after inking an alliance.
27-Sep-2011 - Cambridge Major Laboratories Europe (CMLE) is set to start commercial API manufacturing at its facility in the Netherlands after approval by Dutch regulators.
26-Sep-2011 - ProMetic Life Sciences is supplying an affinity adsorbent to a Chinese biopharm for use in scale-up of a biosimilar.
26-Sep-2011 - Process Systems Enterprise (PSE) has developed crystallisation modelling software to improve throughput and simplify scale-up.
22-Sep-2011 - Oxford Pharmascience expects the challenges facing biopharm to drive interest in its drug delivery and reformulation technologies.
22-Sep-2011 - The FDA has issued a warning letter and import alert to an Indian API manufacturer after finding major cGMP failings.
21-Sep-2011 - Rx-360 has begun its audit sharing programme to increase knowledge about suppliers and the quality of pharmaceutical raw materials.
20-Sep-2011 - The FDA is targeting companies that reformulate drugs to evade enforcement as it tries to crackdown on the 1000s of products marketed without approval.
20-Sep-2011 - Researchers have called for closer monitoring of pharma manufacturing discharges after detecting endocrine disruption in fish downstream from a Sanofi plant.
20-Sep-2011 - Chemicals supplier Lubrizol was bought by Warren Buffet’s Berkshire Hathaway group last week in a deal worth $9.7bn (€7.1bn)
19-Sep-2011 - Use of deoxycholate to chemically disrupt influenza viruses during vaccine manufacture could be linked to adverse reactions in children, a journal reports.
15-Sep-2011 - The FDA needs additional powers to update its “antiquated, domestically-focused statute” and end the “competitive advantage of non-compliance”, an agency official said.
14-Sep-2011 - Albemarle says it will increase what it charges for generic APIs from next month, citing increasing regulatory and testing costs as the main reasons for the hike.
14-Sep-2011 - The FDA has sent a warning letter to Lonza’s Hopkinton, MA plant after inspectors found faults with how it produces an oncology API for Eisai.
14-Sep-2011 - Biocon has begun work on the Malaysian biopharm plant that will serve its deal with Pfizer, and is now providing Lipitor ingredients.
12-Sep-2011 - in-PharmaTechnologist presents a roundup of recent ingredient and formulation research, including using NIR-CI to check quality and microwaves to formulate ibuprofen.
12-Sep-2011 - Lonza Group and Fosun Pharmaceuticals will pump $15.6m (100m yuan) into a joint venture in the Zhangjiang High-Tech Industry Zone, China.
12-Sep-2011 - Lanxess have begun plans to increase its production of thionyl chloride by 20 per cent at its plant in Nagda, India.
07-Sep-2011 - CellCura has inked an agreement with IDT Biologika for the testing and adaptation of its protein-free (PF) media for the production of cell lines for vaccine manufacturing.
07-Sep-2011 - AmerisourceBergen has bought informatics firm IntrinsiQ for $35m (€25m) continuing the spending spree it began earlier this week with the acquisition of market access consultancy Premier Source.
01-Sep-2011 - Royal DSM and Sinochem’s anti-infective manufacturing and distribution JV in China has been given the green light by competition authorities.
31-Aug-2011 - DMV-Fonterra excipients (DFE) will buy Indian manufacturer Brahmar Cellulose Private Limited (BCPL) to strengthen its position in the pharmaceutical excipient market and reduce costs.
31-Aug-2011 - German chemical maker Wacker Chemie is ramping up its sales operations in India, with the country’s rapidly expanding pharmaceutical sector being one of its key targets.