Thursday, 20 December 2012
Aesica looks for new API processes
Aesica has partnered with Durham and Leeds Universities to identify and commercialise alternative technologies for API manufacturing processes. The partnership is supported by the METRC Innovation Award that supports new research between universities and companies in the fields of nanotechnology, science and engineering.
Contract Pharma
Ampac revenues rise
Ampac's fine chemical segment reported FY12 revenues of $111.5m up 25% on 2011. The company attributed this improvement to a recovery from a lag in antiviral product sales in 2011 and to growth from existing or new products.
Seeking Alpha
IGIG acquires Tessenderlo sites
International Chemical Investors Group has acquired the pharmaceutical ingredients activities of Tessenderlo. ICIG has acquired the facilities in Calaire, France, and Farchemia, Italy, to International Chemical Investors Group (ICIG), a private industrial holding company for an undisclosed sum.
In-pharma Technologist
Genmab desperate to sell
Genmab has reduced the fair value of the Brooklyn Park, MN, facility it has been trying to sell for the last few years from $58m to zero. The company will now enter into an aggressive sales process with the aim of closing a transaction in Q1 2013.
Pharma Bio Source
MHRA to seek API details
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) will soon contact UK-based marketing authorisation holders to request data on APIs imported into the UK to ensure they are manufactured in accordance with the EU GMP or, if imported into the EU, with equivalent rules. The MHRA recently said that almost 1200 API plants may require inspection to meet the EU rules.
MHRA
Thursday, 6 December 2012
Wednesday, 5 December 2012
Isochem acquires Wychem
Isochem has acquired kg-scale fine chemical intermediate supplier Wychem. Isochem said the acquisition allows it to offer customers continuity of service and capacities ranging from the kilogram to a hundred metric tons.
Isochem
Dottikon sales and losses increase in H1
Dottikon's first half 2012/13 sales increased 22% to CHF37.7m. However, the company said its production output fell 9% due to unexpected delays in projects and products. Dottikon reported a loss of CHF4.0m for the period.
Dottikon
Hovione drug solubility collaboration with Solvias
Hovione will combine its drug delivery expertise with Solvias' solid state chemistry capabilities in a collaboration focused on the development and GMP supply of pharmaceutical co-crystals. Hovione will use Solvias’ co-crystallisation expertise and crystal design solutions to overcome poor bioavailability and other drug delivery challenges.
Hovione
Wednesday, 21 November 2012
Matthey fine chems perform well in H1
Johnson Matthey reported sales fell 2% to £138m in H1 for its fine chemicals while operating profit rose 14% to £37.2m. Of this, sales in Matthey's API manufacturing business fell 3% to £99m.
Johnson Matthey
Tuesday, 20 November 2012
EFCG calls for mandatory inspections
The European Fine Chemicals Group (EFCG) has proposed global harmonisation of the rules and regulations governing the manufacture of active APIs. The trade group wants to level the worldwide playing field and ensure the quality of APIs and the medicines containing them. EFCG has proposed mandatory inspections for all global API manufacturers through a mutual recognition agreement (MRA) approach managed by national regulatory authorities to share scarce inspection resources and to avoid duplication of effort.
Pharmaceutical Technology
Wednesday, 14 November 2012
Nitto Denko Avecia to acquire Girindus contract manufacturing business
Nitto Denko Avecia will acquire Girindus America's oligonucleotide and small molecule API contract manufacturing business. Nitto Denko Avecia said the acquisition will allow it to offer customers an expanded range of manufacturing capabilities, as well as a second manufacturing facility for security of supply.
Nitto Denko Avecia
Pharma sales flat for DSM
DSM's pharma business reported net sales growth of 1%. However the company said the results were adversely impacted by an uneven delivery pattern at DSM Pharmaceutical Products and by lower margins at DSM Sinochem Pharmaceutical, despite higher volumes. DSM also said it expected business conditions in pharma to remain challenging for the remainder of the year.
DSM
Wednesday, 7 November 2012
Mixed sales performance at AMRI
AMRI reported a 20% fall in sales to $7.4m for Q3 2012 for its development and small scale manufacturing business. The company reported a 14% rise in sales t $9.3m for large scale manufacturing.
AMRI
Monday, 5 November 2012
Lonza to cut jobs at Visp
Lonza will cut 400 jobs at its Visp, Switzerland, site and another 100 in global support functions. The company said that its Q3 2012 performance was on-track and reported steady demand resulting in capacity utilisation as expected in both its chemical and biological custom manufacturing.
Business Week
Thursday, 25 October 2012
EU confirms API import rules
The European Union (EU) has confirmed its new rules regarding the import of APIs into member states. From 2 Jan 2013 all imported APIs must have been manufactured to an EU-equivalent GMP and by 2 July 2013 the importer will need to request and receive written confirmation of this compliance from the relevant regulatory authority.
Pharma Times
Tuesday, 16 October 2012
Dottikon to expand
Dottikon plans to increase its process development and optimisation capacities by 20% and extend its high-pressure technology in heterogeneous and homogeneous catalysis. The company expects the new capacity to be available in H2 2013. Additionally the company will strengthen and expand its catalysis group, including the development and acquisition of high-pressure parallel screening equipment. The company has terminated its talks with Solvias.
Speciality Chemicals
Pharma looks back to the west
Speaking at CPhI Albemarle’s director of fine chemistry services David DeCuir said that the pharma industry is looking back to western suppliers as a result of quality issues, potential interruptions with supplies from Asia and rising costs.
In-pharma Technologist
Wednesday, 10 October 2012
Novasep to build commercial scale chromatography plant
Novasep is investing €30m to build a commercial API chromatography plant in Mourenx, France, to address its projected demand for a large volume, highly purified APIs. The company said it expects the facility to be operational within 18 months.
GEN
Almac readies API manufacturing expansion
Almac has almost completed the expansion of its API manufacturing facility in Craigavon, UK. The upgraded facility, which will be operational by the end of the year, includes the installation of two 1000L reactors and state-of-the-art pressure filter dryer.
Almac
Almac and DSM to collaborate in biocatalysis
Almac and DSM Pharmaceutical Products will partner their biocatalysis capabilities for the manufacturing of APIs. Almac said its expertise in rapid enzyme identification, scale-up and implementation into early phase projects complements DSM’s experience and track record of over 30 commercial manufacturing bioprocesses run on a multi-ton scale.
Pharmaceutical Business Review
Sunday, 7 October 2012
Lonza-Teva biosimilar on hold
Teva has suspended its phase III study of a biosimilar of Rituxan, which it os jointly developing with Lonza. Lonza's shares fell as the company said the partners are evaluating how to move forward with testing as the regulatory environment for biosimilars gets more restrictive.
Fierce Biotech and Business Week
BASF relocates pharma ingredients to New Jersey
BASF will centralise the management of its Pharma Ingredients and Services business unit in Florham Park, NJ. The unit, which was previously managed from Evionnaz, Switzerland, will be led by Scott Thomson as Senior Vice President. BASF said the relocation of management will not affect the regional business and production units in Europe, including Evionnaz.
New Jersey Star Ledger
SAFC expands in Irvine
SAFC will add a powder manufacturing line at its Irvine, Scotland, facility. The expansion will be supported with a £1.5m grant from Scottish Enterprise and will create 24 new jobs.
St Louis Business Journal
Thursday, 27 September 2012
CHP adds capacity
Cedarburg Hauser Pharmaceuticals has expanded its Wisconsin API plant by 50% to meet commercial demand. The company has also added reactor and chiller capacity for GMP cryogenic reactions, made improvements to the air handling systems, installed a reverse osmosis water system, improved isolation capabilities, and upgraded their Emerson DeltaV Digital Automation System.
Cedarburg Hauser Pharmaceuticals
Tuesday, 25 September 2012
Thursday, 20 September 2012
Wednesday, 19 September 2012
Wednesday, 12 September 2012
Tuesday, 11 September 2012
Navidea blames manufacturer
Navidea Biopharmaceuticals attributed the Complete Response Letter from the US Food and Drug Administration regarding its NDA for Lymphoseek to issues with third-party contract manufacturers. In November 2009, Navidea appointed Reliable Biopharmaceutical Corporation for the manufacture and supply of the API for Lymphoseek. Final product manufacturing including final drug formulation, lyophilization and packaging processes for Lymphoseek is performed by OSO BioPharmaceuticals Manufacturing LLC.
Reuters
Boehringer Ingelheim implements disposable biomanufacturing
Boehringer Ingelheim has implemented single-use biomanufacturing at its mammalian facilities worldwide. The system can incorporate different commercially available single-use systems in 100L and 500L GMP facilities for clinical material supplies or for non-GMP process development.
Biopharmaceutical Business Review
Monday, 10 September 2012
Cambridge Major to add capacity
Cambridge Major Laboratories is to expand its large scale API manufacturing facility in Germantown, WI, as a result of growth in demand. The company will add reactor capacity and isolation equipment. Brian Scanlan, President & CEO of Cambridge Major, said that the company's "invest in the West" policy continues to bear fruit. He added that the company is "very well positioned to support both increasing demand for our commercial products as well as our healthy pipeline of API's in later phases of clinical development."
Milwaukee Business Journal
Tuesday, 4 September 2012
Aesica Partners with University of Bradford
Aesica has partnered with the Centre for Pharmaceutical Engineering Science at the University of Bradford. Aesica will benefit from the University's research facilities and the University will gain access to Aesica's GMP manufacturing facilities.
Manufacturing Chemist
Thursday, 30 August 2012
Sales rise for Siegfried in H1
Siegfried reported H1 2012 sales of CHF178.7m up 2.9% on 2011 and profits rose 29% to CHF40.1m. The company said that sales of drug products rose markedly after the launch of new drugs in the first half year, however it's drug substance business passed lower costs for raw materials on to customers.
In-pharma Technologist
Wednesday, 29 August 2012
Ark to concentrate on contract manufacturing
Ark Therapeutics has announced that it will no longer invest in proprietary drug development, outlicense its development assets and focus on contract manufacturing. The company has attracted some contracts for its viral manufacturing expertise over the last year and recently appointed a new ceo with manufacturing experience. Financial analysts were split on the decision. Canacord Genuity believes that Ark has a substantial opportunity as a partner for companies in viral product development while Nomra Code said that the question remains whether the Ark will be able to attract sufficient manufacturing contracts in the near term to attain profitability of its contract manufacturing services business.
Ark Therapeutics
Thursday, 23 August 2012
Carbogen Amcis returns to profit
Dishman reported sales at Carbogen Amcis of $24m for its first quarter. Janmejay R Vyas, chairman and managing director of Dishman Pharma, said that the company has spent 18 months restructuring the Swiss business and that they plan to consolidate in the near future. He expects that Carbogen Amcis will contribute a profit of $7m to Dishman this year.
Business Standard
Wednesday, 15 August 2012
New deal for Cambrex leads to expansion
Cambrex will supply phase III and pre-launch quantities an API for an un-named customer. The company expects the agreement to contribute $20m in 2013. In order to meet the demand under the new agreement, Cambrex will invest significant capital over the remainder of 2012 and in early 2013 to expand our multipurpose large scale cGMP assets.
Cambrex
Ampac fine chemicals returns to profit
Ampac reported fine chemicals revenues of $36.4m in its Q3 2012 up 18% on 2011, led by strong anti-viral products revenues. The company said its fine chemicals activities returned to profit during the quarter which it attributed to redesigned processes and cost savings initiatives.
Seeking Alpha
Monday, 13 August 2012
Fuji Pharma acquires Thai plant
Fuji Pharma has acquired the Olic pharmaceutical manufacturing plant in Ayutthaya province, Thailand, for $53m from DKSH. Charles Toomey, executive vice-president for healthcare business unit at DKSH, said that contract manufacturing is a non-core competency for DKSH and that Fuji has significant manufacturing expertise.
Bangkok Post
Small sales rise and restructuring at DSM
Sales rose 2% to €182m in Q2 2012 for DSM's pharmaceutical business. The company said that business conditions are likely to remain challenging, although it anticipates that it will make further strategic progress. The company also announced a series of restructuring measures including the termination of biosimilar product development by its Percivia joint venture, which will now focus on the existing PER.C6 technology licensing business.
In-pharma Technologist
Thursday, 2 August 2012
Tuesday, 31 July 2012
CMC acquires Xoma facility
CMC Biologics has acquired Xoma's large-scale biologics manufacturing operations Berkeley, CA. The 3100m2 facility includes three 2750L stainless steel bioreactors and two purification suites. CMC expects to begin offering contract manufacturing services from Berkeley when the transaction closes.
GEN
Monday, 30 July 2012
Thursday, 26 July 2012
Custom manufacturing "firm" for Lonza
Lonza reported H1 revenues increasing to CHF1.9bn. The company said demand in its custom manufacturing business was firm, resulting in capacity utilisation above 75% in both chemical and biological plants, as well as a strong project pipeline. Lonza said it had provided a full response to the FDA regarding the 2011 warning letter received at its Hopkinton, MA, plant and that corrective action had been taken. Looking to the future, the company said it has initiated an investment in formulated products.
Reuters
Quarterly record sales for SAFC
Sigma-Aldrich's fine chemicals business, SAFC, reported sales of $223m in Q2, with organic growth of 8% over 2011. Company president and ceo Rakesh Sachdev said "We were pleased by the improved performance of our SAFC custom pharma business, which saw solid growth in cGMP manufactured products in second quarter 2012." Sanchev said the division had double digit sales growth for custom-manufactured high-potency compounds to pharma customers which he attributed to customers recognising the company's investment in HPAPI capacity in Wisconsin.
Seeking Alpha
Thursday, 19 July 2012
Novasep invests in HPAPI manufacturing
Novasep is investing €3m to expand its highly potent API manufacturing capabilities at its Le Mans, France facility. The expansion will allow Novasep to serve the increased demand for manufacturing of novel anti-cancer therapies. The new facility will include the capability to perform cryogenic chemistry at -60C in hastelloy reactors. The company will also add large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale. The plant expansion is expected to be fully operational by the beginning of 2013.
Novasep
Record Q2 for Albemarle's fine chemicals
Albemarle reported record sales in Q2 2012 at $208.7m up 13% on 2011. The company attributed this to favourable volumes and pricing, partly offset by unfavorable foreign currency impacts.
Seeking Alpha
Tuesday, 10 July 2012
Monday, 9 July 2012
Siegfried to build API plant in China
Siegfried, supported by the Chinese development organisation NETDA, will build an API manufacturing plant in Nantong, China. The facility will meet cGMP standards. Siegfried said the site has space for a second phase, which may include finished dosage form production. The new facility is expected to be on-stream in 2014.
Pharmaceutical Business Review
ScinoPharm invests in cytotoxic manufacturing
ScinoPharm will invest $37.6m in the construction of a high potency cytotoxic injectable plant at Tainan Science Park. ScinoPharm said the new facility will include space for R&D, quality control, washing, sterilisation, manufacturing, filling, lyophilisation, packaging, and storage. The company expects the plant to be completed in 2014.
ScinoPharm
Tuesday, 3 July 2012
Dishman to cancel SEZ project
Dishman is to exit its special economic zone in Ahmedebad, India, and sell the land for $108m. In 2009, Dishman merged its engineering SEZ into its pharma SEZ.
Economic Times
Albemarle expands API capacity
Albemarle has expanded and upgraded its API manufacturing facility in South Haven, MI. The new capacity came online on 1 June. The investment at South Haven matches the solids handling equipment with the reactor capacity and Albemare claims it will enable the company to advance its growing portfolio of custom API products.
In Pharm
Amag moves to contract manufacturing
Amag Pharmaceuticals plans to close its manufacturing facility in Cambridge, MA, and is moving to an outsourced manufacturing model. The company will reduce its workforce by 45 as a result of the disposal.
Aman Pharmaceuticals
Tuesday, 26 June 2012
Thursday, 21 June 2012
FDA seeks to secure supply chain
The US Food and Drug Administration is seeking 100 companies to volunteer to join the Secure Supply Chain pilot programme. The programme aims to promote the safety of drugs and active drug ingredients produced outside the US. Applicants will need to meet the programme's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country. The FDA hopes the programme will expedite the entry of products meeting the pilot's criteria into the US and allow it to focus its resources on foreign-produced drugs that fall outside the programme and that may not be compliant.
Regulatory Focus
Wednesday, 20 June 2012
Kalon to manufacture countermeasures
Kalon Biotherapeutics will manufacture medical countermeasures under a contract awarded to The Texas A&M University System to develop one of three US Department of Health and Human Services Centers for Innovation in Advanced Development and Manufacturing.
Kalon Biotherapeutics
Tuesday, 19 June 2012
Fujifilm Diosynth Biotechnologies to expand facilities in UK
Fujifilm Diosynth Biotechnologies is further increasing its contract process development and manufacturing capabilities through the expansion of its services in mammalian cell line development and process development, and the addition of a new multi-product cGMP facility in Billingham, UK. The company said work has commenced on a state-of-the-art cGMP cell bank and 1000L biologics manufacturing facility based upon single-use technology for both upstream and downstream operations. The cell bank manufacturing facility is expected to be available from Q2, 2013 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.
Fujifilm Diosynth Biotechnologies
DSM antibody deal
DSM Pharmaceutical Products will use its XD high cell density process technology to produce antibodies for a major pharma company at its Groningen, The Netherlands, and Brisbane, Australia facilities.
PR Newswire
Lonza has completed the installation of a new GMP clean room in Houston, Texas, for its vaccines and gene therapy business
Piramal negotiating to acquire Cambridge Major
Piramal Healthcare is currently in negotiations to acquire Cambridge Major for around $200m. The report appears to confirm earlier comments by the company. A source lose to the situation, quoted in Financial Express, said "Early stage negotiations are on and it will take a while to conclude the deal." Cambridge Major has not commented on the speculation.
Financial Express
Wednesday, 13 June 2012
Ubichem adds capacity in Hungary
Ubichem has added a new manufacturing site in Budapect, Hungary. Ubichem Pharma Manufacturing's 55,0002 facility will produce starting materials, intermediates and other fine chemical products for pharma and non-pharma applications.
Ubichem
Thursday, 7 June 2012
Strong sales for Johnson Matthey
Johnson Matthey reported that sales for its fine chemical division rose 16% to £285m and operating profit rose 24% to £69.7m. The company said this was boosted by strong demand and supported by a very strong performance from its API manufacturing businesses. Sales in API manufacturing rose 18% to £206m.
Johnson Matthey
Wednesday, 6 June 2012
Piramal looks to acquire
Piramal Healthcare is looking to expand its contract manufacturing business and is already in talks with some contract manufacturing companies in Europe and the US. Chief operating officer, Vijay Shah, said the company wants to scale up the contract manufacturing business to become one of the world's top five.
Live Mint
Tuesday, 5 June 2012
Siegfried adds sterile filling
Siegfried has acquired Alliance Medical Products in Irvine, CA, to add sterile filling services. Siegfried paid $58m in cash with a contingent earn-out consideration subject to AMP meeting defined profitability goals for the fiscal year ended December 31, 2013.
Siegfried
Profits fall at Angel
Angel Biotechnology has reported revenues of £3.456m for the peered ended 31 March. Profits fell from £1.9m to £1.2m partly as a result of the expenditure prepare its Cramlington facility for its initial MHRA inspection. The company plans to continue consolidating its businesses in the coming year.
Proactive Investors
Tuesday, 29 May 2012
Evonik IPO to proceed
Evonik's owners RAG and CVC plan to go ahead with an IPO of the chemicals unit in June. Reports suggest the firm could raise €5bn after delaying the IPO last year.
Reuters
Thursday, 24 May 2012
Codexis and Merck extend collaboration
Merck has extended its catalyst and process development collaboration with Codexis to 2015. Merck will use Codexis' enzyme products to develop more cost- and resource-efficient manufacturing processes for its pipeline of therapeutic candidates. To date Merck has evaluated the use of enzymes across programs in various stages of development and the companies have collaborated to develop enzymes for custom reactions such as for sitagliptin.
Pharmaceutical Business Review
Recipharm to expand
Recipharm plans to use a new €90m loan facility to acquire niche CDMOs, invest in existing facilities and build long term partnerships with major pharmaceuticals companies.
Outsourcing Pharma
Monday, 21 May 2012
Wednesday, 16 May 2012
Carbogen Amcis drags on Dishman
Dishman Pharmaceuticals and Chemicals sales for FY 2012 rose 9% to $208m although profits fell 29% to $10m. The Carbogen Amcis business reported a Q4 turnover of $77m with a loss of $3m although the company expects the unit to grow significantly in terms of topline and bottomline in its 2013 year.
Money Control
Codexis granted patent
Codexis has been granted a US patent covering biocatalytic processes for the preparation of fused bicyclic proline compounds. These compounds are used to make key intermediates in the synthesis of leading hepatitis-C therapeutics.
Codexis
Tuesday, 15 May 2012
AmPac sales revenues rise in Q2
American Pacific's fine chemical division reported Q2 2012 sales of $20.6m up 28% from 2011 primarily due to strong revenues of anti-viral products. However, this was offset by lower oncology products revenues.
In-pharma Technologist
Thursday, 10 May 2012
Mixed Q1 for AMRI
AMRI reported mixed results for its manufacturing units in Q1 2012. Sales fell 7% to $9.8m for its development/small scale manufacturing, and rose 6% to 23.2m for the large scale manufacturing business.
AMRI
Wednesday, 9 May 2012
Pharma weak for DSM
DSM has reported weak Q1 performance in its pharmaceutical facing businesses. However, the company said the first signs of improvement are visible. DSM attributed its 7% growth in sales to a better performance at DSM Pharmaceutical Products and slightly better prices at DSM Sinochem Pharmaceuticals.
DSM
Tuesday, 8 May 2012
Lonza's Q1 in line with expectations
Lonza reported its business performance was in line with expectations in the first quarter of 2012 and that its custom manufacturing business has continued pipeline development and signed new contracts ranging from pre-clinical to commercial products. The company also reported that capacity utilisation in both chemical and biological manufacturing was 75%.
Lonza
Carbogen Amcis looks east
Dishman Pharmaceuticals & Chemicals is refocussing its Carbogen Amcis subsidiary by expanding from its traditional Europe and the US markets towards Japan and other territories. In addition, Dishman has reduced manpower at Carbogen Amcis bringing down the wage bill significantly. The company said these changes are expected to strengthen Carbogen Amcis' financial performance in the fourth quarter of the fiscal 2012.
Business Standard
Cambrex Q1 sales rise
Cambrex reported a 14% increase in Q1 sales to $70.6m and EBITDA increased by 41% to $15.6m. The company attributed the increase in sales to higher volumes of controlled substances and generic APIs.
Cambrex
Thursday, 3 May 2012
Pfenex anthrax contract renewed
US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) has exercised its option to extend its contract with Pfenex to develop a production strain and process for the production of bulk recombinant protective antigen (rPA) from anthrax. Under the contract Pfenex will continue to develop an rPA-based anthrax vaccine from rPA produced in Pseudomonas fluorescens. To date, Pfenex has demonstrated that a strongly immunogenic, stable and protective form of rPA could be expressed and recovered from the highly efficient fermentation of a strain of P. fluorescens engineered to produce rPA.
Pfenex
Wednesday, 25 April 2012
Ark plant receives approval
The Finnish Medicines Agency (FIMEA) has extended Ark Therapeutics' GMP certification to include its newest and largest production facility in Kuopio, Finland. The 650m2 facility has been designed for larger scale production from suspension cell cultures utilising state-of-the-art single use systems and includes an automated fill and finish line capable.
Ark Therapeutics
Strongest Q for SAFC
In its strongest quarter ever, SAFC reported sales of $197m in Q1 2012. The company said the organic sales growth rate for SAFC in the first quarter was in the low single digits but it expects sales growth to move from low-mid single digits in the first half of the year to low double digits for the second half.
Seeking Alpha
Tuesday, 24 April 2012
£800k deal for Angel
Angel Biotechnology will develop and manufacture a recombinant interferon product for TransGenRx at its Cranlingon, UK, faulty. As part of the £800,000 deal Angel will work to attain acceptable expression levels on which to establish a GMP manufacturing process, which would then be conducted by Angel.
Angel Biotechnology
Monday, 16 April 2012
Thursday, 12 April 2012
Wednesday, 11 April 2012
Tuesday, 3 April 2012
Sigma-Aldrich acquires Research Organics
Sigma-Aldrich has acquired Research Organics, Inc. to expand its buffer production capacity and to increase its portfolio of raw materials for the biopharmaceutical and diagnostic markets. Sigma-Aldrich will merge Research Organics into its SAFC business unit.
St Louis Business Journal
CIA seeks companies for UK pavilion at CPhI
The UK's Chemical Industries Association is seeking expressions of interest from UK-based companies offering products and services within the fine chemical industry interested in exhibiting on a UK pavilion at CPhI in Madrid, Spain, during October.
For more information contact CIA
Fujifilm Diosynth Biotechnologies expands R&D capabilities
Fujifilm Diosynth Biotechnologies has completed the first phase of a £3m investment in new equipment and laboratories at its Billingham, UK site. The company has refitted its microbial fermentation laboratory to including eight new in-situ sterilisable 20L fermenters and a number of bench-top high-throughput units. Additionally, the company has added a new suite of R&D laboratories for process development work and plans to further additions in Billingham and at its North Carolina site.
Contract Pharma
Wednesday, 28 March 2012
Angel's Cramlington facility runs again
Angel Biotechnology has completed the re-commissioning of its Cramlington, UK, facility. The company is now seeking to transfer processes from its Edinburgh facility en route to GMP certification.
Angel Bio
Tuesday, 27 March 2012
Monday, 26 March 2012
Saltigo realignment hits Lanxess
Lanxess Q4 2011 income fell to €5m, down 80% from €26m in 2010. The company attributed this to a €20m charge for the realignment of the pharma business of the Saltigo business unit.
Lanxess
Thursday, 22 March 2012
Novasep completes recapitalisation
Novasep has completed its previously-announced recapitalisation. The €310m arrangement includes €30m of new capital invested by France’s strategic investment fund, which has become a shareholder in Novasep. Additionally, Azulis invested 3 million euros in equity. The company said it now has more than €40m in cash available for financing growth projects.
Novasep
Manufacturing oversight bill proposed in US
In an effort to improve the tracking of drugs imported into the US, Senator Michael Bennet has published a discussion draft of a bill that would strengthen manufacturer quality standards by improving tracking of foreign manufacturing sites and requiring all manufacturers to register with FDA. The Senator also proposes that manufacturers submit information on the regulatory status, facility information, cGMP and "any other information deemed necessary" for imported drugs before entering the country.
US Senate
Wednesday, 14 March 2012
Recipharm to commercially manufacture Plenadren
Recipharm will commercially manufacture Plenadren for ViroPharma. As part of the agreement, ViroPharma will investing in new equipment at Recipharm to increase the manufacturing capacity for Plenadren. Although Recipharm will be able to use the new equipment for other projects, manufacturing for ViroPharma will be the highest priority.
Recipharm
DSM extends contract with Agennix
DSM Pharmaceutical Products has extended its process development and manufacturing agreement with Agennix to include commercial manufacture of talactoferrin, an oral dendritic cell mediated immunotherapy.
Pharmaceutical Business Review
Evonik IPO plans revived
Evonik's partial owner CVC has said that the company could now be listed by the end of June. A partner in CVC said that the robust start to the markets this year meant that the conditions for an IPO were more suitable now than when the Evonik IPO was shelved last year.
Reuters
Monday, 12 March 2012
Wednesday, 7 March 2012
Thursday, 1 March 2012
Boehringer expands biopharma capabilities
Boehringer Ingelheim has invested €17m to expand its biopharmaceutical development and manufacturing capabilities in Biberach, Germany and Vienna, Austria. The company said the expansions will enhance state-of-the art cell line development and process development services for the contract manufacturing business. Additionally, the company has expanded its current GMP cell banking, process science, cell line development and quality laboratories.
European Pharmaceutical Review
Wednesday, 29 February 2012
Girindus partners with Axolabs
Girindus has partnered its oligonucleotide manufacturing with Axolabs analytical capabilities to offer a complete service solution for therapeutic oligonucleotides from early discovery and preclinical development through clinical stages and into commercialisation.
GEN
Monday, 27 February 2012
Thursday, 23 February 2012
Jubilant HollisterStier signs four contracts
Jubilant Life Sciences subsidiary, Jubilant HolisterStier, has signed manufacturing contracts, worth over $90m in total, with four life sciences firms. The company will manufacture sterile parenteral products for the US and European markets.
Economic Times
Monday, 20 February 2012
Codexis appoints interim CEO
Codexis has appointed Peter Strumph, Senior Vice President and Business Head of Pharmaceuticals, as interim CEO following the surprise decision by Alan Shaw to step down. The company said Shaw resigned to pursue other interests, but will will continue to serve as a special advisor to the Board of Directors.
San Francisco Business Journal
Thursday, 16 February 2012
Asymchem adds capacity
Asymchem has completed phase 1 of a new large scale manufacturing facility in Dunhua, China. Operating under the name Jilin Asymchem Laboratories Co. Ltd the $20m facility includes 5,000-20,000L vessels for the limited cGMP manufacture of raw materials to intermediates. A second phase, which will be completed in July 2012 will add a second module for a total capacity of 532m3. The third phase, due online in October 2012, will increase capability through GMP manufacturing of APIs and API intermediates. Asymchem plans a further $12m investment in Dunhua between 2012 and 2014 for additional downstream commercial projects.
Pharmaceutical Business Review
Tuesday, 14 February 2012
OmniChem expands in Belgium and India
OmniChem has commissioned a new facility for the development and manufacturing of HPAPIs and intermediates in Wetteren, Belgium. The new facility has increased OmniChem's capacity in class 5 HPAPIs by 11,200-liter reactor capacity. Additionally, OmniChem's Indian joint venture Granules-OmniChem has broken ground on a $20m manufacturing facility in Visakhapatnam.
OmniChem
Business Standard
Chemoxy spins out from Dow
The UK facilities of Dow Haltermann Custom Processing have been spun out from Dow Chemical with a management buy-out backed by the Royal Bank of Scotland. The business, which has sites at Middlesborough and Billingham in the UK, has been renamed Chemoxy International, the company's former name. The firm will employ about 80 people an is seeking to grow by 5-10% this year. Managing director, Ian Stark, said "we are going to be more agile as an SME and we’re looking to bring back on line some plants that were idle a few years ago."
Speciality Chemicals
Monday, 13 February 2012
Sunday, 12 February 2012
Lonza to form South African JV
Lonza has confirmed it is negotiating with the South African Government to establish a $206m JV, called Ketlaphela, for the establishment of a manufacturing facility for anti-retroviral medicines. The discussions are still at an early stage and nothing has been signed. South African Science and Technology Minister Naledi Pandor has said production should start in 2016 and create 2200 jobs. The South African Industrial Development Corporation and other state institutions will invest $129m, Lonza will invest more than $64m and South Africa's state chemical company, Pelchem (Pty) Ltd., will contribute land and facilities worth $13m. Lonza said that the discussions are still at an early stage and nothing has been signed.
Reuters-Yahoo
SAFC continues to grow sales
Full year sales at Sigma Aldrich rose 10% to $2.5bn, with the SAFC business growing 9% during the year. The company said it expected the SAFC business to show low to mid single digit growth in the first half of the year and low double digit growth in the second half of the year as additional capacity comes on line in China and Taiwan.
Seeking Alpha
Revenues rise for AMPAC
AMPAC reported a 55% increase in fine chemicals segment revenues to $21.5m in its Q1 2012. Dana Kelley, AMPAC vice-president, CFO and treasurer, said that revenues from antiviral products were the primary contributor to the rise as the 2012 first quarter included no antiviral product revenue. Joe Carleone, AMPAC president and CEO, said the company had recently agreed to produce controlled substances for a large pharmaceutical customer and will soon be conducting a full scale validation of a chemical product in this area.
Seeking Alpha
Lonza's new factory concept
Lonza is establishing a new manufacturing concept at its Vis, Switzerland site. The company said that continuous flow and microreactor technologies will allow it to offer increased flexibility and capacity for the development and manufacture of APIs. Lonza added that the facility will be ready for full operation in June 2012.
Manufacturing Chemist
Contract manufacturing sales up for AMRI
Contract manufacturing sales at AMRI rose in 2011. The company reported a rise of 4% to $36m for its development and small scale manufacturing and 20% to $95.6m for large scale manufacturing.
AMRI
Sales rise at Cambrex; looks to acquire
Cambrex reported a sales rise of almost 6% to $67.1m in Q4 2011, which the company attributed to increased demand for an API manufactured under a long-term supply agreement, a recently approved innovator product, higher sales of generic APIs, and higher volumes of controlled substances and products utilising its drug delivery technology. Cambrex CEO, Steven Klosk, said the company is looking to add further capabilities in generic finished products.
In-pharma Technologist
Saturday, 11 February 2012
Codexis looks to future
Codexis' full year 2011 product revenue rose 49% to $49.0m as a result of increased sales to both generic and innovator pharmaceutical customers. Codexis President and CEO, Alan Shaw, said that in 2012 the Codexis' customers received FDA and EMA approvals for three new on-patent drugs using the company's technology. Shaw said he expects to see improved sales growth in 2012. Additionally he said Codexis is expecting the FDA to approve the manufacturing process for blockbuster pharmaceutical product, which has approaching $4bn in sales. He sees additional growth from increased volumes of generic atorvostatin using the company's technology and more companies using their products in their process development.
Codexis
Wednesday, 8 February 2012
New contract for Angel
Angel biotechnology has signed three new manufacturing contracts with Materia Medica Holding, worth £4.5m. Angel will start the projects at its Edinburgh facility before transferring later this year to its refurbished, larger site at Cramlington, UK.
The Herald
Aesica to expand HPAPI capabilities
Aesica is to upgrade its API manufacturing capabilities to enable the company to manufacture high potency APIs at commercial scale. Following the upgrade, Aesica will be able to manufacture SafeBridge Category 3 API and formulated products from pilot to commercial scale at two of its sites in Europe.
Aesica
Thursday, 2 February 2012
Wednesday, 1 February 2012
Q3 sales rise at Johnson Matthey
Johnson Matthey's fine chemicals division reported sales up 15% to £62m in its Q3 ended 31 December 2011. The company said its API manufacturing business performed well aided by sales of a new API for the treatment of drug addiction. Looking forward Matthey said the underlying performance of the division is more predictable and it continues in line with expectations.
Johnson Matthey
SAFC gets BioReliance
Sigma-Aldrich has completed its acquisition of BioReliance from Avista Capital Partners for $350m. BioReliance's services will be folded into Sigma-Aldrich's SAFC custom manufacturing and services business unit.
Maryland Daily Record
Tuesday, 31 January 2012
Indian manufacturing pact for DSM
Mumbai, India-based Indoco Remedies will manufacture eight APIs for DSM's pharmaceutical products business unit. DSM said the alliance will leverage Indoco's product development and cGMP manufacturing capabilities and DSM's market access. Additionally DSM said the deal fits with its global expansion plans.
Hindu Business Line
Wednesday, 25 January 2012
Lonza results miss estimates, fires CEO
Lonza has reported its full year 2011 revenues before the Arch acquisition of CHF2.5m, up 5% in constant exchange rates, missing analyst estimates. The company also announced that its CEO, Stefan Borgas, would be leaving the company with immediate effect. Lonza's share price fell 13% on the day the results were announced.
Lonza said its custom manufacturing continued to benefit from demand for outsourcing from pharmaceutical and biotech companies. The company said its capacity utilisation rate for small molecules was 78% and for biological molecules was 87% excluding the recently opened Singapore facility and it had increased the number of contracts it had signed.
Outsourcing Pharma
Strong year for Albemarle
Albemare reported a strong Q4 and full year 2011 for its fine chemistry business unit. Sales in Q4 rose 36% to $209m and income 62% to $43m. For the full year the unit reported record sales of$750m up 32% and income doubles to $140m. The company said that the unit is set for another strong year in 2012.
Seeking Alpha
Monday, 23 January 2012
Thursday, 19 January 2012
Avecia Biotechnology plans acquisition
Avecia Biotechnology has identified a possible acquisition target that would expand its capabilities. Company President Detlef Rethage said it has chosen a company in the fill and finish business. Avecia has not indicated when the acquisition would be completed.
Mass High Tech
AMRI UK site receives GMP certificate
AMRI’s Holywell, UK, manufacturing facility has received a GMP certificate following an inspection in October 2011. The site also passes a US FDA audit in June 2011. AMRI said the former Excelsyn facility can now produce registered intermediates and active ingredients for use in humans and expands the range of projects that it can now conduct at this facility.
AMRI
Tuesday, 17 January 2012
Molecular Profiles to expand cGMP capacity
Molecular Profiles is adding a new £9m manufacturing facility at its Nottingham, UK, site. The new facility, which is due to open later this year, will add 3000m2 of space and provide six new GMP suites, new laboratories and a clinical packing suite. It is designed to enable flexibility of use and the manufacture of highly potent compounds up to OEB 4 level.
InPharm
Carbogen Amcis acquires Creapharm
Dishman Pharmaceuticals subsidiary Carbogen Amcis has acquired Creapharm Parenterals for an undisclosed sum. The business, which will be renamed Carbogen Amcis SAS, adds complimentary formulation and lyophilisation services as well as sterile GMP-standard capabilities for the rapid supply of medicines, including highly potent compounds for preclinical and clinical trials to Carbogen Amcis.
Pharma Times
Monday, 16 January 2012
Tuesday, 10 January 2012
Future of AMRI's Hungary facility in doubt
AMRI is considering options for its custom research and manufacturing facility in Budapest, Hungary. The company said the site had been losing money over the last two years and the company is considering transferring the activities to other sites.
Outsourcing Pharma
