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AMRI posts loss, but forecasts 23% contract rev growth in Q4

10-Nov-2010 - 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

10-Nov-2010 - 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.

Visualisation of FDA overseas inspections by year & type

03-Nov-2010 - 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.

Overseas FDA offices bring benefits but planning needed

28-Oct-2010 - Overseas FDA offices have realised immediate benefits but strategic planning is needed to ensure the ventures, critical aspects of the agency’s ability to ensure drug quality, are long-term successes according to the GAO.

FDA may never have inspected 88 per cent of Chinese sites

27-Oct-2010 - The FDA may never have inspected 88 per cent of the 920 Chinese facilities in its inventory, according to the GAO.

Lilly to close Singapore R&D unit; double sales force in emerging markets

20-Oct-2010 - Eli Lilly has unveiled plans to close its Singapore R&D centre by the end of the year and relocate discovery operations to its global headquarters in the US.

IDT sees big potential in vaccine contracting

18-Oct-2010 - IDT Biologika.says demand for vaccines in emerging markets is big chance for Big Pharma and hence a growing niche for contractors with the technical capabilities to carry out such work.

Exclusive interview

Biopharm sees large future for media enhanced packaging

14-Oct-2010 - Biopharm sees a large future for packaging containing digital codes that can link mobile devices to content, according to Catalent.

Stemedica & AnC form stem cell production joint venture

14-Oct-2010 - Stemedica and AnC Bio have formed a joint venture to manufacture stem cells for the treatment of ischemic stroke and other degenerative disorders.

Almac invests in biocatalysis lauding cost and environmental benefits

13-Oct-2010 - Almac invests $4m in biocatalysis R&D, describing such technologies as the way forward for the cost efficient production of highly chiral APIs and intermediates.

Pharmatek ‘roll’ out new equipment to expand GMP manufacturing capabilities

13-Oct-2010 - Pharmatek Laboratories has once again expanded service offerings at its San Diego, California facility by adding two roller compactors to its solid oral dosage form manufacturing capabilities.

Zydus Nycomed API site to start production in December

30-Sep-2010 - Zydus Nycomed expects commercial production at its newly commissioned API plant in Navi Mumbai, India to begin in December 2010.

Chinese cancer drug brings HUYA and Quintiles together

29-Sep-2010 - HUYA Bioscience International will co-develop a new Chinese cancer drug, HBI-8000, with Quintiles for the “benefit of cancer patients globally.”

DSM seeks Asian partners; welcomes J&J Crucell takeover

23-Sep-2010 - DSM aims to keep pace with the rapid evolution of pharmaceutical sector through increased partnering and a focus on Asia.

IDT Biologika plans viral vacc expansion

22-Sep-2010 - IDT Biologika unveils plans to expand viral vaccine contract manufacturing operations and says global capacity failing to keep pace with resurgence in drug industry demand.

News in brief

Life Technologies to out-license CHO cell lines recombinant proteins

20-Sep-2010 - Life Technologies has concluded license agreements, providing rights to its proprietary Chinese hamster ovary (CHO) cell lines for production of recombinant proteins used as therapeutic agents and vaccines.

Rexam and Med Time team on compliance packaging solution

16-Sep-2010 - Rexam and Med Time Technology, a US manufacturer of plastic prescription vials, have launched “Pill Timer,” a packaging solution designed to boost treatment compliance rates.

Grace to buy Synthetech for chiral expertise

14-Sep-2010 - Industrial catalysis firm WR Grace moves for struggling Synthetech to boost pharmaceutical intermediates and chiral chemistry offering.

Genzyme sells genetics lab; amid talk of staff cuts

13-Sep-2010 - Genzyme has confirmed plans to sell genetic testing unit to LabCorp for $925m amid media rumours that 1,000 employees face redundancy.

Bend adds hot-melt tech to boost solubilisation service

09-Sep-2010 - Bend Research is bolstering its hot-melt extrusion service capabilities by installing new equipment at its contract manufacturing site.

Update

GSK taps Lonza for bio plant knowledge; sells R&D site to Galapagos

08-Sep-2010 - GSK will work with Lonza on the development of a UK biomanufacturing plant as part of a new MAb manufacturing contract announced today.

Update

DSM launches InnoSyn route scouting service for process R&D

07-Sep-2010 - DSM Pharma Chemicals, a business unit of DSM Pharmaceutical Products, has announced the launch of InnoSyn route scouting services, meeting pharma needs to outsource process development R&D.

Cipla looking at 25% Cipla Medpro investment

07-Sep-2010 - Indian drugmaker Cipla may invest in South Africa’s Cipla Medpro to boost manufacturing capacity and improve access to rapidly expanding African pharmaceutical markets.

Colorcon adds Turkey coating lab to tap regional markets

06-Sep-2010 - Colorcon says proximity to emerging drug manufacturing markets was key driver for new Turkey technical service lab.

Aurobindo supplying AZ with generics for emerging markets

06-Sep-2010 - Aurobindo Pharma is to supply AstraZeneca with solid dosage and sterile generic products for sale in emerging products.

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