Friday, 10 October 2008
Almac offers solid state services
Almac has added a Solid State Chemistry business to its pharmaceutical operations. Based in Craigavon, Northern Ireland, the team specialises in solid form characterisation, screening and selection, in addition to crystallization process development.
Almac
CPhI Innovation award winners
Novozymes Biopolymer won the Gold award at the 2008 CPhI Innovation Awards for its HyaCare hyaluronic acid process. Pierre Fabre Medicament won the silver award for its Formulplex "green" formulation process and Dr Reddy's precatalyst fabrication technology the bronze.
CPhI
Thursday, 9 October 2008
Ferro sells fine chems unit
Ferro Corporation has sold its fine chemicals business to Arsenal Capital Partners for $66m. Following the deal, which is expected to close by the end of the year, the business will be renames Novolyte Technologies.
RTT News
Friday, 3 October 2008
Wednesday, 1 October 2008
SAFC commissions HPAPI facility
SAFC Pharma has commissioned a high-potency API conjugates suite at its St Louis site to support oncology drug development. The suite will accommodate early-stage clinical supplies with the capability to expand production up to commercial-scale.
Pharmaceutical Online
Aptuit streamlines early stage drug development
Aptuit has launched a new programme to speed the early stages of drug discovery. Indigo aims to support development from discovery through to proof-of-concept and includes API manufacturing, toxicology, metabolism/pharmacokinetics, clinical supplies and regulatory application.
Aptuit
SAFC increases API capacity by 15%
SAFC Pharma has begun operation of a new reactor at its Arklow, Ireland, site. The 6000L reactor, which is part of a $4m project, increases SAFC's API production capacity by 15%. SAFC is also carrying out two further enhavcements in Arklow: a $2.25m pilot-scale filter dryer due for commission in Q32009; and a $1.8m expansion of warehouse capacity due for completion in 2009.
Sigma_Aldrich
Monday, 29 September 2008
CMC Biologics to expand capacity
CMC Biologics will expand capacity at its Bothell, WA, contract manufacturing facility five-fold as part of a $35m expansion plan. CMC expects the project to be completed by mid-2010.
Seattle Times
Piramal launches clinical trial supplies and acquires CRO
Piramal Healthcare has launched a clinical trials supply service from its Morpeth, UK, facility. The company has also acquired a Romanian clinical trials management company, Tangent Data s.r.l., which will be integrated into its contract manufacturing business.
Piramal Healthcare
Excelsyn upgrades Holywell
Excelsyn has added Fauske adiabatic and TSU calorimetry equipment at its Holywell, Wales, site and is now able to conduct stability testing in-house. Excelsyn has also added laboratory-scale hydrogenation capability. These additions are part of the recently completed initial phase of its three-year expansion and upgrade programme at Holywell.
Excelsyn
Thursday, 25 September 2008
Wednesday, 24 September 2008
Pfizer to use sonocrystallisation
Pfizer will use Prosonix's Prosonitron reactor and sonocrystallisation technology in its API production at its manufacturing facilities in Ireland. Prosonix claims the technology allows the control of many aspects of complex pharmaceutical crystallisation processes, including control of crystal size, shape, and purity, the selective production of polymorphs, enhancing both manufacturing productivity and ultimate formulation performance of drug product.
In-Pharma Technologist
Monday, 22 September 2008
RohnerChem to scale up EnCat
RohnerChem is to scale up Reaxa's EnCat technology. The companies have previously worked on initial screening and process development for the encapsulated catalysts.
In-Pharma Technologist
Thursday, 18 September 2008
Wednesday, 17 September 2008
Pharmatek opens high potency facility
Pharmatek has opened its 1800m2 highly-potent and cytotoxic facility in San Diego. The new development includes analytical and formulation development laboratories and cGMP manufacturing suites.
Pharmatek
Tuesday, 16 September 2008
DSM-LibraGen amine technology deal
DSM and LibraGen will co-develop new omega-transaminases for production of chiral amines. LibraGen will use its enzyme discovery and development to identify enzymes to convert ketones to optically pure amines. DSM will produce the enzyme using its fermentation capabilities and PluGbug expression platform.
LibraGen
Significant growth in Excelsyn sales
Excelsyn saw like-for-like sales increase 43.5% to $28m for its year ended 31 May. The company attributed the growth to an acceleration in volume demand and customer numbers for its pharma synthesis business and continuing growth in outsourcing of development and manufacturing services. Excelsyn ceo Ian Shott said the company's strategy, introduced in January, was delivering a significant upturn in business.
Excelsyn
Thursday, 11 September 2008
Lonza expects more outsourcing, plans acquisitions
Lonza CFO Toralf Haag has said the company expects to benefit from the pharma industry's continuing trend towards more outsourcing. He also said the company has CHF1.5bn-2bn ($1.3bn-$1.8bn) available for acquisitions in the next year.
The Guardian
Tuesday, 9 September 2008
FDA revises cGMP guidelines
The FDA has amended its cGMP requirements for finished pharmaceuticals. This amendments concern aseptic processing, verification of performance of
operations by a second individual, and the use of asbestos filters. The FDA said it changes were to "modernise or clarify some of the requirements as well as to harmonize them with other FDA regulations and international cGMP standards". The amendments which are the first phase of an incremental approach to modifying the cGMP regulations will be effective from 8 December 2008.
FDA
Sunday, 7 September 2008
SOCMA plans for "Last 100 days"
SOCMA intends to ensure that legislation key for the success for its members does not fall by the wayside during the last 100 days of the Bush Administration. SOCMA will be meeting regulatory agencies overseeing unfinished business to urge completion of its priority issues as well as ensuring that the McCain and Obama campaigns are aware of these issues.
SOCMA
SAFC confirms HP-API expansion plans
Sigma-Aldrich has confirmed plans for a $30m expansion of its SAFC high potency API facility in Madison, Wisconsin. SAFC has purchased 15 acres of land in Verona, Wisconsin, for the 4500m2 facility, which will include development laboratories, a 150L mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4000L. Construction is expected to be completed by end-2009.
In-Pharma Technologist
Dishman plans Carbogen Amcis IPO
both acquired by Solutia in 2000. Solutia rebranded the businesses as Solutia Pharmaceutical Services before formally merging them into a single legal entity: Carbogen Amcis in 2006. Dishman acquired Carbogen Amcis from Solutia in May 2006 and has made a number of investments in the business over the past two years.
Sify Business
Tuesday, 2 September 2008
Sunday, 31 August 2008
Dishman builds Carbogen Amcis facility
Dishman is building the biggest oncology and high potency drugs facility in Asia at its Bavla plant. The Rs500m ($11m) facility is being commissioned by Dishman's Carbogen Amcis subsidiary, which will also operate the facility. In addition, Dishman Pharmaceuticals is investing Rs5bn ($115m) in two special economic zones near Bavla. The chemicals and pharmaceutical zone is expected to house 50 facilities and the engineering zone 100 facilities. Work on the zones will start before the end of the year.
Business Standard
Financial Express
Wednesday, 27 August 2008
CNOOC to establish fine chemicals park
CNOOC, the China National Offshore Oil Corp, as part of its current strategy to expand beyond its traditional upstream businesses will construct a fine chemical industrial park in the Shenzen special economic zone bordering Hong Kong. CNOOC has signed a memorandum of understanding with the government of Shenzhen city to jointly develop the park.
Trading Markets
Tuesday, 26 August 2008
Codexis expands Arch deal
Codexis has expanded its three-yeas strategic collaboration with Arch Pharmalabs. Codexis' Indian subsidiary will offer multiple pharmaceutical intermediates and APIs made with its biocatalytic processes, including intermediates used to manufacture generic atorvastatin (Lipitor), as well as the API itself.
Codexis
Dishman looks to $200m manufacturing contracts and acquisition
Dishman Pharma is currently in talks for $100-200m for its contract research and manufacturing business. Managing director, JR Vyas, puts this down to pharma companies exiting API manufacturing. Dishman is seeking an Asian acquisition to establish Carbogen Amcis as a full-service oncology package provider.
Money Control
Thursday, 21 August 2008
Jubilant invests in North America
Jubilant Organosys is integrating its North American operations. Jubilant will align Canadian Draxis Health with US subsidiary Hollister-Stier. Jubilant has also initiated a $20m capacity expansion programme.
Business Standard
Tuesday, 19 August 2008
Thursday, 14 August 2008
Tuesday, 12 August 2008
Sunday, 10 August 2008
SAFC to expand HP-API capabilities
SAFC Global is to expand its high potency API manufacturing capabilities with a new 4500m2 plant in the Verona Technology Park in Wisconsin. SAFC expects to close the deal for its $30m facility on 15 Aug. The company plans to break ground in October, complete construction in 2009 with a production starting in early 2010.
Verona Press
Thursday, 7 August 2008
API challenge for Cambrex
Despite Q2 sales rising 5% to $66.2m, Cambrex said its marginon sales decreased to 29.9% from 37.9% of sales. Cambrex said its lower sales of generic APIs were partially offset by higher custom manufacturing revenues. The company put the decrease in margins down to an unfavorable product mix, lower pricing on its largest API, and higher costs associated with the validation of the new API finishing facility in Milan, Italy.
Cambrex
Wednesday, 6 August 2008
New Institute aims to improve fine chemical processes
University of Leeds, UK, will link its research capacity with commercial needs for the fine chemical sector through its new Institute of Process Research and Development. The iPRD includes teams from the University’s School of Chemistry and School of Process, Environmental and Materials Engineering. The new institute, which is funded by industry as well as public funds, aims to develop production processes with greater efficiency and lower impact.
iPRD
NME approvals down in H1 2008
The FDA has approved only six NMEs in the first half of the year. In H1 2007 the agency approved seven. The approval level is usually similar in the second half of the year, which could mean this year is one of the wort for approvals.
In Vivo
Thursday, 31 July 2008
Wednesday, 30 July 2008
Call for FDA overhaul
A leading member of the US House of Representatives and a leading Congressman have called for a major overhaul of the nation's drug regulator. Representative John Dingell and Senator Chuck Grassley say there should be a taller wall between the agency and the industry it regulates. In addition they have called for the FDA to be given the authority to recall drugs, to impose significant fines on drug companies for safety violations and to inspect generic-drug makers before approving a new product. In addition, they want the next president to appoint a tough FDA commissioner completely independent from the industry. It is unlikely that any changes will happen before the elections in November, but next year may see significant changes to the FDA.
Wall Street Journal
Sunday, 27 July 2008
Lonza predicts weaker H2, expands Hopkinton site
Lonza reported a 83% rise in first-half net profit boosted by the sale of its stake in Polynt SpA. However the company said underlying performance was "on track despite currency and raw material challenges". Lonza ceo Stefan Borgas said the company will have a "weaker" second half than the first as a number of biopharmaceuticals customers have postponed projects until next year. Lonza is adding a state-of-the-art, high-titer 2000L microbial fermentation manufacturing train in Hopkinton, MA. The plant, which is due onstream in March 2009, will meet customer demand for mid-scale microbial manufacturing.
Reuters
Bloomberg
Lonza
SAFC record sales, expects slower growth
Sigma-Aldrich's SAFC fine chemicals division reported 11% growth in Q2 and sales of $170.4m - a third successive quarter with a sales record for the company. However, the company has reduced its growth expectations from 8-9% to 5-6% as a result of "recent economic and industry conditions and discussions with customers". The company is still looking at acquisitions that may further enhance growth.
Sigma-Aldrich
Tuesday, 22 July 2008
FDA to send workers overseas by end 2009
The US FDA expects to station employees in in China, India, Europe and Latin America to improve the safety of exports of food and drugs by the end of 2009. Workers will be stationed in the Middle East at a later date.
Bloomberg
Q2 sales rise for Albemarle's fine chemicals
Albemarle saw a 15% increase, to $151.9m, in net sales for its fine chemicals business in Q2. The company attributed the rise to higher volumes and improved pricing. However income for the sector declined $1.8m to $24.5m.
Albemarle
Sunday, 20 July 2008
Thursday, 17 July 2008
Tuesday, 15 July 2008
Ranbaxy faces US probe over quality
Federal prosecutors in the US claim Ranbaxy has misled the US government about the quality of its generic medicines and are seeking access to documents from the Indian company. Ranbaxy says the allegations are baseless.
Business Week
Economic Times
Sunday, 13 July 2008
Lonza in development deal with Novartis
Lonza has entered a strategic partnership with Novartis for the scale up development and production of its pipeline of biotechnology drugs. Under the long-term partnership each product will have a specific development agreement. Lonza will provide process development and manufacturing capabilities from its R&D centre in Slough, UK, and manufacturing capacity in the US, Spain and Singapore.
Smart Money
Ranbaxy Fine Chemicals eyes US acquisition
ICICI Ventures is planning to support its Ranbaxy Fine Chemicals Ltd company in the acquisition of the fine chemicals division of Mallinckrodt Baker. The $400m deal will treble the size of RFCL.
NDTV
