USP building database of fake & substandard meds
The USP is building a database of counterfeit essential medicines to support international drug procurement organisations, such as WHO, and the timely sharing of information between national regulators.
Eden Biodesign becomes cGMP provider for PER.C6 technology
Crucell and Eden Biodesign have entered into an agreement that sees Eden become a provider of services of contract manufacturing services for Crucell's PER.C6 cell-line technology.
Joint API inspection pilot a success, says EMA
The European Medicines Agency (EMA) says 12-month API plant joint inspection programme has fostered greater collaboration between international drug industry regulators and cut the number of duplicate visits.
Gerresheimer expands Indian presence with Mumbai office
Gerresheimer will open a representative office in Mumbai India this week as part of its growth strategy to capitalise in emerging markets.
AMRI posts loss, but forecasts 23% contract rev growth in Q4
API maker AMRI cited arbitration costs, efforts to address a US FDA warning letter and acquisitions as key factors in Q3 loss, but predicted that large-scale contract manufacturing business will drive final quarter gains.
No inspections of heparin sites in China in 20 months pre-crisis
In the 20 month period before the heparin crisis no Chinese producers were inspected by the FDA and efforts during and since have been hindered by legal and practical challenges.
Blue Bird Circle to help form clinical research centre at Texas Children’s Hospital
Volunteer organisation, the Blue Bird Circle will provide grants of $1m to Texas Children’s Hospital in the US for the establishment of a new clinical research centre.
FDA may be having difficulties in Puerto Rico, says US oversight cmttee
The US FDA’s Puerto Rico office may be “having difficulty” monitoring drug manufacturing in the country according to the Congressional Committee on Oversight and Government Reform.
Adding Indian cGMP HPAPI capabilities builds on Arch’s strategy of differentiating through technology and establishes it in an emerging and profitable sector.
ATMI acquires Artelis in ‘disposables’ deal
ATMI has acquired Artelis, a Belgian biotech firm, in an effort to “get closer to customers” by widening its disposable technology portfolio to the life sciences research and manufacturing sector.
West’s drug delivery sales spark rise in Q3 profits but packaging profits drop
Sales and profits increased at West Pharmaceutical Services in Q3, but rising manufacturing costs hit drug packaging systems earnings.
RecipharmCobra’s French customers to get tax breaks
RecipharmCobra Biologics has called for more R&D tax breaks in Europe after French Ministry of Higher Education and Research recognises it as key provider.
Overseas offices will shorten inspection times during crises
Overseas offices will help the FDA schedule inspections more quickly in times of crisis but, as yet, employees based abroad have visited relatively few facilities.
in-PharmaTechnologist presents interactive charts visualising FDA overseas inspections by type and year, as well as the proportion of sites that may never have been inspected.
Agilent opens new LCMS plant in Singapore
Agilent Technologies has opened a new instrument plant in Singapore to boost capacity for LC/MS production and drive expansion across Asia.