18-Aug-2014 - All three of the manufacturers announced recalls late last week either for potential contamination or cGMP (current good manufacturing practice) deviations.
14-Aug-2014 - GMP failures at an aseptic plant owned by SCM Pharma are part of a wider industry trend affecting several sterile sites in the UK, according to the ex-owner of the CDMO.
14-Aug-2014 - Over the next few months Sanofi and non-profit PATH are delivering the first large-scale batches of an artemisinin-based combination therapy to five African countries, which will for the first time be manufactured with semi-synthetic artesunate.
13-Aug-2014 - Merck Millipore, the life science division of Merck KGaA, will invest €12m ($16m) at its Molsheim, France facility to expand its ready-to-use media manufacturing capabilities and capacity.
11-Aug-2014 - For the third time since last August, Cubist Pharmaceuticals has recalled lots of its antibiotic Cubicin injection due to the potential of glass particulates in a manufacturing line produced by an unnamed CMO (contract manufacturing organization).
05-Aug-2014 - The European Medicines Agency (EMA) has issued a concept paper on transferring quality control methods validated in collaborative trials that is intended to encourage the uptake of better tests in terms of the replacement, reduction and refinement of the use of animals in tests.
05-Aug-2014 - Fresenius Kabi has recommenced production at a troubled Indian facility and expects to start shipping APIs to the US in the next few weeks.
04-Aug-2014 - China has tightened its GMP requirements and compliant API suppliers will benefit from a reduction in competition, according to ScinoPharm.
31-Jul-2014 - Hospira has reached “a major milestone” in its remediation efforts at its troubled Rocky Mount plant following a US FDA inspection which resulted in zero observations.
30-Jul-2014 - Impax Laboratories said it is working to address issues raised in an FDA Form 483 for its Taiwanese manufacturing facility, which was cited with 10 observations following an inspection in late July.
30-Jul-2014 - Zhejiang Jiuzhou Pharmaceutical has received an FDA warning letter after shipping a misbranded active pharmaceutical ingredient to the US.
29-Jul-2014 - Robust quality systems differentiate Biocon from other Indian manufacturers, the firm says, despite political turmoil in the Middle East and North Africa impacting first quarter 2015 sales.
28-Jul-2014 - Hikma has bought defunct manufacturer Ben Venue and says it could reactivate the site in the long-term, despite the transfer of equipment across its sterile injectables network.
23-Jul-2014 - As the International Conference on Harmonisation (ICH) signs off on a new tripartite guideline related to elemental impurities, the European Pharmacopoeia Commission will revise its texts to ensure consistency.
21-Jul-2014 - The US FDA is looking to up its cooperative agreements with PAHO (Pan American Health Organization) as part of an effort that could bring as much as $10m over five years to the Latin American version of the WHO (World Health Organization).
17-Jul-2014 - Three batches of the seizure drug midazolam made by UK CMO Penn Pharma are being recalled over concerns that packaging problems may affect its concentration.
17-Jul-2014 - The CDSCO has accused international “vested interests” of labelling counterfeit drugs as “made in India” to damage the reputation of the country’s pharmaceutical industry and launched a scheme to reward people who report fakes.
16-Jul-2014 - Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.
15-Jul-2014 - Although industry group PhRMA has called for the full implementation of a proposed rule that would allow the US FDA to destroy detained drugs deemed to be counterfeit or unapproved, the group also warns that such destruction could lead to manufacturing delays.
10-Jul-2014 - Pharma technology provider Waters as agreed with the Chinese Pharmacopoeia Commission (ChP) to establish a joint open laboratory to develop new pharmacopoeia standards.
This method describes near-infrared spectroscopy in diffuse reflection for determining residual moisture in a lyophilized pharmaceutic...