The Challenge of Change - Managing Excipients Control
Colorcon
05-Jan-2012 - R&D software firm Accelrys says it will speed up the pharma QA/QC process and reduce the compliance risk ten-fold through its $35m takeover of VelQuest.
05-Jan-2012 - The US Food and Drug Administration (FDA) will soon start asking drugmakers to play a greater role in guideline development . Before that process begins in-Pharmatechnologist.com takes a look at the documents published by the agency in 2011.
03-Jan-2012 - The European Commission (EC) has set out its plans for ‘equivalence assessments’ for manufacturers in countries seeking to export APIs to Europe.
02-Jan-2012 - India has released draft guidance on stability data needed to support approval of Phase I to III clinical trials.
22-Dec-2011 - Pall will buy US instrument maker ForteBio next year in a continuation of efforts to build its biomanufacturing technology offering.
21-Dec-2011 - Ranbaxy has signed a consent decree with the US FDA and set aside $500m for penalty payments to settle its longstanding dispute.
20-Dec-2011 - Counterfeit anti-malarials containing the Viagra API were probably manufactured in Southeast Asia, researchers found.
19-Dec-2011 - Manufacturers of certain critical drugs must report production interruptions to the FDA under a new interim final rule.
19-Dec-2011 - GE Healthcare wont say if its new turnkey biologics plant development service will offer Governments in emerging nations discounted rates.
15-Dec-2011 - A treaty on medicine quality is needed to fix the major public health problem of substandard drugs, according to academics.
14-Dec-2011 - GE Healthcare and M+W Group aim to capture a share of the rapidly expanding global biologics market with a new plant and manufacturing tech partnership.
14-Dec-2011 - The EMA has recommended recalling a batch of Gilead’s Vistide manufactured by Ben Venue over particle contamination concerns.
13-Dec-2011 - ADC Biotechnology (ADC Bio) has secured a development grant for a new antibody drug conjugate (ADC) manufacturing technology that, it says, can make drug production cheaper.
13-Dec-2011 - The FDA and the EMA will begin sharing facility inspection data in their respective territories from January to make better use of resources and reduce drugmakers’ inspection burdens.
08-Dec-2011 - Mettler Toledo says its new dissolved oxygen (DO) measuring optical sensors can speed up the API production process and reduce maintenance costs.
07-Dec-2011 - Bosch Packaging Technology says melt extrusion is the answer to drug manufacturers’ active pharmaceutical ingredient (API) solubility questions.
05-Dec-2011 - The Ethiopian national quality control laboratory has gained ISO accreditation to improve access to safe medicines.
01-Dec-2011 - Biologics Modular is leasing its mobile production facilities to help clients make FDA regulated drugs without fixed plants.
01-Dec-2011 - Large volume production is a must for the cell therapy sector according to ATMI, which claims the latest addition to its single-use bioreactor range can help manufacturers overcome the GMP hurdles that hinder commercial scale-up.
01-Dec-2011 - The drug industry's need to improve product quality while reducing production costs is driving global demand for testing technologies according to Sepha.
01-Dec-2011 - Ranbaxy has introduced generic Lipitor in the US after partnering with Teva and gaining FDA approval for manufacture at its US plant.
30-Nov-2011 - Novo Nordisk has stopped using living animals in batch quality tests after developing a virus filtration tool for factor VII production.
28-Nov-2011 - Industry reluctance to share information on economic adulteration is hindering FDA efforts to tackle tainted ingredients, a GAO report found.
24-Nov-2011 - A Pfizer Ireland plant has become the first in its network to achieve ISO accreditation for cutting CO2 emissions and energy use.
23-Nov-2011 - The EMA is recalling cancer drugs manufactured by CMO Ben Venue Laboratories after inspectors found quality shortcomings.