AMRI is to take additional actions to streamline its operations in 2012. During Q4 2011 AMRI has reduced its workforce, reduced capacity and reduced operating costs. The company hopes these actions "will better align the business to current and expected market conditions and are expected to improve the company’s overall cost competitiveness and increase cash flow generation". AMRI said the reduction will primarily affect its US operations and will terminate the lease of one of its US facilities. AMRI expects that these cost-reduction initiatives will result save $10-11m per year.
Times Union
Wednesday, 28 December 2011
AMRI restructures for 2012
Tuesday, 20 December 2011
Sunday, 18 December 2011
GE and M+W to build biopharma manufacturing plants
GE Healthcare and M+W Group have formed a partnership to offer an integrated, "turn-key" approach for the construction of biopharmaceutical manufacturing plants, to help meet the rapidly increasing worldwide demand for these potentially life-saving treatments. The alliance is targeted at emerging countries.
Bloomberg BusinessWeek
Lonza expands early phase manufacturing in China
Lonza has completed the expansion of it snarly phase manufacturing capacity in Nansha, China. Lonza has added a new cGMP kilo-lab and an additional small scale train to meet the growing demands of its global small molecule customers.
Manufacturing Chemist
Tuesday, 13 December 2011
EMA and FDA to collaborate on GMP inspections
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are to share work on inspections of manufacturing sites in each other's territories, starting in January 2012. The initiative builds on a pilot programme which ran earlier this year. Initially the programme will focus on inspections of manufacturing sites in the EU or US that are already known to the two authorities and have a history of compliance with GMP following previous inspections.
InPharm
Australian biologics facility moves closer
DSM Biologics and the University of Queensland’s Australian Institute for Bioengineering and Nanotechnology (AIBN) have signed a memorandum of understanding to construct and run Australia’s largest biologics scale-up facility in Brisbane. The Aus$65m facility, which is currently under construction, will be owned by Biopharmaceuticals Australia and will be run by DSM Biologics. The AIBN will collaborate on early stage biologics development.
Australian Life Scientist
Wednesday, 7 December 2011
Novasep restructures balance sheet
Novasep has completed a restructuring of its balance sheet with its creditors. Additionally the French Fonds Stratégigue d’Investissement (French Strategic Investment Fund) has become a new investor in the company, which as abandoned its plans to merge with Minakem.
Speciality Chemicals
Tuesday, 6 December 2011
Shasun aims for growth
Shasun Pharmaceuticals Managing Director S Abhaya Kumar has said the company aims to double its annual revenues to $389m, within four years, by increasing exports. The company is currently adding new API manufacturing capacity in Vizag, India, and expanding capacity in Newcastle, UK.
Economic Times
Monday, 5 December 2011
Thursday, 1 December 2011
Vivimed acquires Uquifa
Vivimed Labs has acquired Yule Catto's Uquifa pharmaceutical ingredients business for £35m. Uquifa operates three manufacturing sites, two in Spain and one in Mexico. Mark Robbins will remain CEO of Uquifa. Vivimed said the acquisition would strengthen its current position in pharma APIs and intermediates while significantly improving the cost competitiveness of Uquifa.
Economic Times
Wednesday, 30 November 2011
Sales fall at Dottikon
Dottikon reported H1 sales fell by 14% year-on-year to CHF30.8m and a net loss of CHF2.7m. The company said it had reached its "prospective bottom" and had ended short hours working.
Dottikon
Thursday, 24 November 2011
Strong sales for Johnson Matthey
Johnson Matthey's Fine Chemicals division reported sales 16% higher at £142m in the six months ended 30 September. The company said its return on sales fell slightly as a result of the impact of a restructuring programme at Macfarlan Smith. Johnson Matthey is planning to use its Conshohocken, US, facility to manufacture intermediates and final products at lower cost and higher efficiency, enabling the company to rationalise global production and secure new business which could not have been targeted previously.
Johnson Matthey
Tuesday, 22 November 2011
Aesica opens potent products plant
Aesica has opened its £3m manufacturing facility for potent products in Queenborough, Kent, UK. Aesica said the new facility will significantly enhance and extend its capabilities in terms of formulated products and the packaging of solid dosage forms. The new facility gives Aesica the capability to manufacture products classified as SafeBridge Category 3 and Schedule II controlled drugs such as opiates.
Kent Online
Tuesday, 15 November 2011
Thursday, 10 November 2011
UK companies receive government support
Aesica Pharmaceuticals, Piramal Healthcare and Shasun Pharma are to share £2m of funding from the UK government's Regional Growth Fund with two other companies. The companies will use the funding to expand their international activities.
News Post Leader
Tuesday, 8 November 2011
Manufacturing revenues up for AMRI
AMRI reported a flat Q3 2011 with sales of $50.2m, however sales for its manufacturing services rose. AMRI's development/small-scale manufacturing revenue was up 8% to $9.2m and large-scale manufacturing revenue increased 17% to $25.7m.
AMRI
Cobra acquires Unitech
Cobra Biologics has acquired Unitech Pharma Group and its bio-production facility in Matfors, Sweden. The company said the acquisition is part of its strategy to expand its service offering. The Matfors facility will which add a 600L clinical and commercial microbial GMP production capacity, commercial aseptic fill/finish and lyophilisation capability to Cobra's portfolio.
Outsourcing Pharma
Strong Q3 sales at Cambrex
Cambrex reported that sales in Q3 2011 rose 18% to $58.2m including a 7% rise due to favourable exchange rates. The company said that higher volumes of an API for a customer who experienced a disruption in its supply chain for most of 2010, higher volumes of controlled substances, products utilising its drug delivery technology and a recently approved innovator product were the main reasons for the rise. These were partially offset by lower pricing across several product categories, lower sales of generic APIs and lower custom development shipments.
Cambrex
Thursday, 3 November 2011
Wednesday, 2 November 2011
Tuesday, 1 November 2011
Chemie Uetikon acquired by Barclays and management
Barclays Private Equity has acquired a majority shareholding in CU Chemie Uetikon from CPH Chemie + Papier Holding AG. Barclays, which has acquired 90% of the Lahr, Germany-based company, said it and the company's management will pursue a consistent growth strategy in pharmaceuticals, cosmetics and nutrition industries.
Uetikon
Capacity utilisation up at Lonza
In its Q3 2011 business update Lonza said its underlying business appears on track to deliver growth through 2011. The company said that capacity utilisation in its pharma-facing custom manufacturing businesses remains high - about 90% for biologics and about 83% for chemicals. The company said it still faces challenges from the strength of the Swiss Franc, raw material headwinds and continued competition in life science intermediates.
Reuters
Monday, 31 October 2011
Fujifilm to manufacture ContraFect biologic
Fujifilm Diosynth Biotechnologies will use its pAVEway advanced protein expression technology at its Billingham, UK, facility to support the process development and cGMP manufacture of CF-301, ContraFect’s Staphylococcal-specific bacteriophage lysine.
Manufacturing Chemist
Lonza to manufacture GenMab's HuMax-TF
Lonza will provide process development and cGMP manufacturing for Genmab’s monoclonal antibody HuMax-TF in its Slough, UK facility. The antibody, which is expressed using Lonza’s GS Gene Expression System, will be conjugated at Lonza's plant in Visp, CH to a cytotoxic drug to form the antibody drug conjugate.
GEN
Monday, 24 October 2011
Almac to increase manufacturing capacity
Almac is expanding manufacturing capacity to over 30m3 at its Craigavon, UK, headquarters. The company said the facility will include reactor vessels with state of the art clean room product isolation and drying equipment to allow HPAPI manufacture up to 600kg batch size. Almac anticipates that the facility will be built, commissioned and validated within the next two years.
Almac
Layoffs at Corden
Corden Pharma Colorado, the former Roche Colorado facility recently acquired by ICIG, is to lay off 60 of its 260 workers.
Boulder County Business Report
Thursday, 20 October 2011
Almac to expand pharmaceutical development capabilities
Almac will invest £4.5m in the first phase of expanding pharmaceutical development capabilities at its headquarters in Craiavon, Northern Ireland. The new laboratory scale facility, which is due for completion in mid-2012, will provide non-GMP formulation facility for the development and scale-up of solid oral dose drug products using a range of technologies. The second stage of the expansion will add dedicated analytical laboratories before the end of 2012.
Genetic Engineering and Biotechnology News
Carbogen Amcis and Polymun Scientific to team on HPAPI technologies
Carbogen Amcis will collaborate with Polymun Scientific to offer additional services for the development, manufacturing and formulation of HPAPIs. Carbogen Amcis will gain access to Polymun's innovative liposome technology for the formulation of APIs and Polymun will have access to Carbogen Amcis' expertise in the development and manufacture of highly potent APIs.
Carbogen Amcis
Wednesday, 19 October 2011
Hovione collaborates with Bend Research
Hovione and Bend Research will collaborate to offer their clients access to each other's capabilities. Bend Research will offer its clients access to Hovione’s commercial-scale pharmaceutical manufacturing facilities and Hovione clients will have access to Bend Research’s oral drug-delivery, formulation, and engineering expertise.
Bend Research
Monday, 17 October 2011
Angel to establish jv
Angel Biotechnology is to establish a joint venture with Materia Medica Holding (MMH). The jv, which will be 51% owned by MMH and 49% owned by Angel, will commission new product programmes and manage their production in a dedicated GMP unit operated by Angel, on behalf of MMH. To manufacture products for MMH, Angel plans to increase the size of the GMP facility at Cramlington.
Proactive Investors
Profits fall at Aesica
Aesica's pre-tax profit in 2010 fell from £9.7m to £3.4m as sales fell slightly from £84.6m to £83.5m. The company said the closure of its Ponders End facility in London generated exceptional costs of £6.8m, including £3.1m primarily relating to redundancy payments.
Insider Media, Yorkshire
Saltigo to add HPAPI manufacturing capabilities
Saltigo is adding the capabilities to produce potent and highly potent APIs at its Redmond, WA, facility. Andreas Stolle, head of Saltigo's pharma business line, said the kilogram scale facility, aimed at supplying materials for phase I and II, will be available early in 2012. Additionally, Saltigo's Leverkusen site has been accredited by the Japanese Pharmaceuticals and Medical Devices Agency.
Saltigo
Wednesday, 5 October 2011
Carbogen Amcis completes inspection
Carbogen Amcis has successfully completed a US FDA pre-approval inspection for a new high potency drug. for a US multinational. Dishman's managing director JR Vyas said: "Post this approval, we expect business of around $10m per annum from our existing customers."
Money Control
Aesica gets new investor plans expansion
Silverfleet Capital has replaced LDC as the majority investor in Aesica. Silverfleet's investment will enable Aesica to continue its rapid expansion into new markets and achieve its vision of becoming the number one supplier of APIs and formulated products to the global pharmaceutical industry.
Contract Pharma
Thursday, 22 September 2011
Amrutanjan to start custom manufacturing
Amrutanjan Health Care Ltd plans to offer custom manufacturing services through its fine chemicals subsidiary, Amrutanjan Pharmaessence Pvt Ltd. The company has signed a memorandum of understanding to provide contract manufacturing for Sigma Aldrich.
Business Standard
Tuesday, 20 September 2011
Lonza plans Singapore listing
Lonza will list on the Singapore stock exchange later this year. The secondary listing on the Main Board of the Singapore Exchange Securities Trading Limited is designed to give the company a more visible presence in Asia, allowing it to tap the strong capital flows in Asia, and enlarging and broadening its current investor base in the region, said Stehan Borgas, Lonza's ceo.
Channel News Asia
Thursday, 15 September 2011
Jubilant's $70m contract
Jubilant Life Sciences' Jubilant HollisterStier facility in Montreal, Canada, will manufacture a product for a US pharma company. The deal is worth $70m over the next four years. Economic Times
Warning letter for Lonza
Lonza has received an FDA warning letter following cGMP violations in the production of Eisai's Ontak at its Hopkinton, MA, facility. Lonza received the letter after failing to address issues raised in inspections during April and May. The FDA cited Lonza for inadequate or lack of an investigation of critical deviations or a failure of a batch to meet its specifications or quality standards; failure to validate analytical test methods used for API for potency testing; and failure of its quality unit to exercise its responsibility to ensure that APIs manufactured are in compliance with CGMP, including meeting established specifications for quality and purity. In-pharma Technologist
Monday, 12 September 2011
Wednesday, 7 September 2011
Lonza and Fosun to establish jv
Lonza and Shanghai Fosun Pharmaceutical plan to create a jv in Pudong Zhangjiang High-Tech Industry Zone. The two companies will jointly invest CNY100m ($15.6m). Lonza has said that five drugs will be produced by the jv. Capital Vue
Fareva acquires Pfizer plant
Fareva has acquired Pfizer's Henrico, VA, plant and will invest $42m in the facility. Fareva will keep the current 500 employees at the facility and planes to add more over the next five years. As part of the agreement, Fareva will manufacture products for Pfizer for six years. Richmond Times-Dispatch
DSM and Sinochem anti-infectives jv
DSM has established a Hong Kong-based 50/50 global joint venture for its business anti-Iinfectives with Sinochem. Under the jv agreement Sinochem has paid €210m for a 50% equity interest in the business group. The new organisation will be called DSM Sinochem Pharmaceuticals Limited. DSM
Sales grow for Siegfried
Siegfried reported a 28.3% rise in sales to CHF173.8m in H1 2011. Siegfried attributed the growth to a significant increase in API sales, particularly in exclusive synthesis. The company said its strategy is on track and it has the necessary funds for implementation of the strategy. Siegfried
Thursday, 25 August 2011
New rules for Chinese contract manufacturers
China's State Food and Drug Administration (SFDA) is clamping down on its drug contract manufacturing companies. The SFDA aims to prevent the export of counterfeit products.
Sidley
Wednesday, 24 August 2011
Contract manufacturing to double in next 10 years
Business information provider Visiongain predicts that global contract manufacturing revenues will double from 2011 to 2021. The company says revenues will reach $64.07bn in 2016 - with a CAGR of 8.7% between 2010 and 2016 - driven by manufacturing of finished dosage forms.
Pharma Times
Monday, 22 August 2011
BI plant to exit contract manufacturing
Boehringer Ingelheim's Ben Venue laboratories facility in Ohio is to cease contract manufacturing activities and focus on generics operations. Contract manufacturing work will be transitioned to other Boehringer plants over the next few years.
Nasdaq
Monday, 15 August 2011
Congress to pass plant inspection law
The US Congress is expected to pass new legislation that will enable the FDA to inspect overseas generic drug manufacturing facilities every two years. Generic drug manufacturers will pay fees totalling $299m/year to fund the inspections in return for speedier approval of products.
New York Times
Fine chemicals revenues rise at Ampac
Revenues at Ampac Fine Chemicals rose 55% to $30.8m in its Q3 2011 compared to 2010. The company attributed this to increases in revenues from core products in its key therapeutic areas including a 139% rise in revenues from anti-viral products.
Seeking Alpha
Onyx acquired by Ipca Laboratories
Onyx Scientific has been acquired by Ipca Laboratories for £4.6m. The UK-based business will be operated as part of Ipca's Covenance custom manufacturing business unit.
North East Business
Thursday, 11 August 2011
Wednesday, 10 August 2011
Tuesday, 9 August 2011
AMRI Q2 revenues rise
AMRI reported that Q2 2011 revenues for its development/small scale contract manufacturing rose 18% to $9.1m and for its large scale contract manufacturing rose 21% to $25.5m over 2010.
Albany Business Review
Roche Colorado acquired
ICIG is to acquire Roche Colorado and its Boulder, CO, manufacturing facility for an undisclosed fee. ICIG will operate the business as part of its Corden Pharma unit and rebrand the facility as Corden Pharma Colorado. The facility will continue to supply Roche with a number of APIs.
In-pharma Technologist
Joint inspection programme reports
The EMA, the FDA and Australia's Therapeutic Goods Administration have concluded their joint inspection pilot programme. During the two pilots the agencies exchanged more than 250 documents relating to 54 different medicines and organised 13 collaborative inspections of clinical trials. As a result, the agencies will continue with their collaboration on inspections and build on the lessons learned during the pilot phases.
Wall Street Journal
Monday, 8 August 2011
DSM seeks CMO partner in Asia
DSM is seeking a partner in Asia for its pharmaceutical products custom manufacturing unit. The company is looking to serve new clients in Asia and smaller customers to reduce its reliance on its current large pharma customer base.
Outsourcing Pharma
Tuesday, 2 August 2011
DSM pharma sales slow
DSM reported that sales for its pharma-facing business unit fell to €178m in Q2 2011 from €195m in the same period in 2010 and H1 sales fell to €341m from €381m. The company said that its pharma sales and results improved compared to Q1, but it is conscious that overall performance of the cluster remains below acceptable levels. DSM attributed the lower Q2 sales to the weaker US dollar and lower volumes at DSM Pharmaceutical Products.
DSM
Wednesday, 27 July 2011
Currency puts pressure on Lonza
Lonza's sales fell 5% to CHF1,193m in H1 2011, with the company reporting pressures of unfavourable exchange rates. However, the company reported that it had increased its project pipeline in both chemical and biological manufacturing. Additionally the company said its capacity utilisation was around 80% for both parts of its custom manufacturing business.
Reuters
Tuesday, 26 July 2011
Monday, 25 July 2011
Cellectis reaches Lonza milestone
Just over a year after announcing it would use its meganuclease technology to deactivate glutamine synthetase in Lonza's CHO cell line, Cellectis bioresearch claims it has succeeded. Lonza said the achievement will enable it to make further improvements to its GS Gene Expression System and shorten development timelines.
Bioscience Technology
Thursday, 21 July 2011
Ajinomoto and Granules announce API jv
Ajinomoto OmniChem and Granules India Limited have established a joint venture, Granules-OmniChem Private Limited, to provide contract manufacturing of APIs. The company, which will be based in the Pharmacity SEZ zone in Vishakhapatnam, Andhra Pradesh. It will start construction of its $20m manufacturing facility in November 2011, and expects to start production by January 2013.
India Infoline
Monday, 11 July 2011
Lonza to buy Arch
Lonza has made an approved offer of $1.4bn for Arch Chemicals. The deal will give Lonza a word-leading presence in microbial control and will reduce the companies dependence on contract manufacturing.
NYT Deal Book
FDA approves 20 drugs in H1
The US FDA approved 20 new drugs in the first half of 2011. Last year it approved 21 in the whole year. While the agency said that it was meeting more than 90% of approval deadlines, there is a feeling amongst some commentators that this approval rise in approval rate is a blip possibly a clearing of a backlog of applications.
Wall Street Journal
Tuesday, 5 July 2011
Recipharm spins out biologics facilities
Recipharm has established a holding company for its biologics development facilities in Sweden and the UK. The shareholders in the new company, Cobra Biologics Holding which will continue to trade as RecipharmCobra Biologics, are its management team, Zentricity Holding and Recipharm. Recipharm has decided to concentrate on its core business activities.
Recipharm
Unions call for Lonza talks
The Unia and Syna unions, which represent workers at Lonza's Visp site, have called for talks with the company, following its decision to extend working hours. The unions said the move was unacceptable and an affront to personnel and unions. Unia said staff should not have to work longer to ensure Lonza turns a profit and called for immediate talks on the issue.
Swiss Info
Thursday, 30 June 2011
Prosonix secures funding
Prosonix has raised £11.4m in Series B funding to move its pipeline of proprietary mono and multi-component combination respiratory therapies through phase II clinical trials. Ventech led the round with Gilde Healthcare Partners joining existing investors the Entrepreneurs Fund, Solon Ventures and Quest for Growth. David Hipkiss, Prosonix's CEO said "these new funds will allow us to attain key performance and clinical data for our pipeline of advanced fast-to-market respiratory programs that will deliver significant added value and benefits to patients and payors alike."
In-pharma Technologist
Tuesday, 28 June 2011
Senator calls on FDA to tighten outsourcing rules
US Senator Sherrod Brown has called on the FDA to tighten its oversight of outsourcing of API production by US pharmaceutical companies. The Senator said: "When drug companies outsource pharmaceutical ingredients, they also outsource drug safety standards. It's simply unacceptable to allow drug companies to skirt existing regulations by importing ingredients from countries with lax safety standards. Drug company profits cannot come at the expense of consumer safety. Pharmaceutical companies must be able to guarantee the safety of their products and trace the origin of their ingredients.”
Sherrod Brown
Fujifilm and Mitsubishi enter partnership
Mitsubishi has acquired a 20% stake in Fujifilm's Fujifilm Diosynth Biotechnologies US and UK business units. Following the deal Mitsubishi and Fujifilm will jointly mange the two business units "to strongly promote the expansion of the biopharmaceutical contract manufacturing business". Fujifilm completed the acquisition of the business from Merck in April.
Fujifilm Diosynth Biologics
Monday, 27 June 2011
CMC expansion almost complete
CMC Biologics has almost completed the expansion of its biomanufacturing production facility in Bothell, WA. The expansion will add a 3000L bioreactor train to increase commercial manufacturing.
Pharmaceutical Business Review
CABB acquires KemFine
CABB has paid €140m to acquire KemFine from 3i. KemFine, which is headquartered in Helsinki and operates a production facility in Kokkola, Finland, had sales of €81m in 2010. Uwe Kolb, partner responsible for CABB's investors Bridgepoint’s investment activities in the German speaking countries, said: "KemFine is a good fit with our recent acquisition of CABB where our aim is to drive further growth through investments in new technology and new capacities, regional expansion projects and further bolt-on acquisitions.”
Bloomberg
Tuesday, 21 June 2011
FDA plans new approach to drug imports
The FDA has launched a plan to improve the safety of pharmaceutical products being imported into the US. The plan includes partnerships and data sharing with regulators across the world.
Wall Street Journal
Pfizer applies for QbD pilot
Pfizer is the first company to apply for the European Medicines Agency's (EMA) and the US Food and Drug Administration's (FDA) 'quality by design' pilot programme. The programme aims to achieve increased co-operation in drug evaluations between the agencies.
PM Live
Thursday, 16 June 2011
Dishman shifts focus
Dishman Pharmaceuticals and Chemicals Ltd is planning to shift its focus from low-margin to high-margin products in a bid to boost profits. The company is also re-structuring its Carbogen Amcis subsidiary to bring it back on a growth track.
Business Standard
Monday, 13 June 2011
Thursday, 9 June 2011
Pfenex to develop processes for SAFC
Pfenex will engineer production strains and processes for SAFC’s contract manufacturing customers. The developed processes will ultimately be transferred to SAFC’s recently expanded fermentation facility in Jerusalem, Israel for cGMP production. The companies will also work together to combine Pfenex’s Reagent Proteins product offerings in the area of vaccine components with SAFC’s expertise and facilities for bioconjugation to support development of conjugate vaccines.
Contract Pharma
Lonza expands in Singapore
Lonza will expand its biopharmaceutical development services platform in Singapore. the CHF10m investment will add 1858m2 of state-of-the-art laboratory space and associated equipment. The additional facilities will support cell line construction, upstream and downstream process development, and analytical services. Lonza said the new facility will come on-line in H1 2012.
GEN
Wednesday, 8 June 2011
Sales fall at Dottikon
Dottikon reported a 30% fall in sales to CHF80.1m for the year ended 31 March 2011 compared to 2010 and a net loss of CHF7.1m compared to income of CHF12.6m the previous year. The company said the main contributor to the sales decline was a 37% fall in sales of pharmaceutical products as a result of several discontinued and delayed customer projects in the late development phase, together with persistent price and currency pressure.
Dottikon
Sunday, 5 June 2011
Capacity and costs drive outsourcing
A recent survey of the pharma and biopharma community has revealed that 54.% of organisations outsource less than half of their global manufacturing and that 18.2% currently outsource over 90% of their output. Lack of internal capacity and cost savings were the two key reasons for outsourcing.
GPCM
Matthey sales grow
Johnson Matthey's fine chemicals business division ended the year to 31 March with revenues up 14% to £255m and sales up 11% to £245m. The company said it saw good sales growth in its API manufacturing businesses and expects that the division will continue to grow steadily in 2011/12 as a result of increasing demand for its APIs, new product introductions and the additional capacity following the acquisition of the Conshohocken, NJ plant 2010.
Johnson Matthey
Tuesday, 31 May 2011
Ubichem Research acquired
The majority share of Ubichem Research has been acquired by Lochlomond Holding, a financial investment company. The company is now independent of Ubichem Plc in the UK.
Outsourcing Pharma
Sunday, 29 May 2011
FDA launches inspections database
The US FDA has launched an Inspections Database. The searchable resource includes names and addresses of inspected facilities, inspection dates, types of FDA-regulated products involved, and final inspectional classification.
FDA
Monday, 23 May 2011
CIA seeks companies for UK pavilion at CPhI
The UK's Chemical Industries Association is seeking UK-based companies offering products and services within the fine chemical industry for a UK pavilion at CPhI in Frankfurt, Germany, during October.
For more information contact CIA
Thursday, 19 May 2011
Gallus acquires site, plans expansion
Gallus Biopharmaceuticals has acquired Johnson & Johnson's Centocor biologics campus in St Lousis, MO, following an equity investment by Ridgemont Equity Partners. Ridgemont has taken a majority stake in Gallus. Gallus will retain 160 jobs at the facility and plans to expand the facility’s manufacturing capabilities, including building a clinical services suite and expanding the existing development lab, and add 160 further jobs over the next five years.
Ridgemont
St Louis Today
Wednesday, 18 May 2011
Lonza expands in Houston
Lonza will build a state-of-the-art cGMP clean room for its viral-based therapeutics business in Houston, TX. The clean room will include large-scale capacity to support late-stage viral vaccine and gene therapy projects. By utilising disposable process systems it will support production and fill/finish operations of up to 2000L.
Lonza
Tuesday, 17 May 2011
Codexis transfers processes to Teva
Codexis has completed the technology transfer of custom biocatalysts for manufacture of three pharmaceutical products to Teva. Two products have been transferred to pilot manufacturing and a third to full scale commercial manufacturing. Codexis' biocatalysts are being used in reengineered process steps in the manufacture of covered generic products
In-pharma Technologist
Monday, 16 May 2011
Fine chemicals revenues decline at Ampac
Revenues for American Pacific's fine chemicals division fell from $43.2m in 2010 to $30m in 2011 for the six months ended 31 March. The company said this was primarily due to a 92% decline in revenues from anti-viral products, which the company expects to resume in the second half of 2011.
AmPac
Successful inspection at CML facility
Cambridge Major Laboratories has undergone a successful FDA inspection at its two manufacturing sites. The inspection of its Germantown, WI, large scale facility is the first at the site. The company also said the FDA has approved the product, which is the first commercial product produced in the large scale facility.
BioSpace
Lonza to expand cytotoxic manufacturing in Visp
Lonza will invest CHF24m to expand its cytotoxic manufacturing capabilities in Visp, Switzerland. The company will add multi-kilogram scale cytotoxic production capacity, which will allow it to offer clinical and commercial production, to its current gram scale high potency GMP laboratory suites. The expansion is expected to be completed in Q2 2012.
Lonza
Thursday, 12 May 2011
Monday, 9 May 2011
Six inspections at Hovione plants
Hovione facilities have undergone six successful GMP inspections in the last eight months. Sites in China and Portugal have been inspected by the Japanese PMDA; the Portuguese authorities inspected a site in April and the US FDA inspected the Loures site twice and New Jersey once.
PR Newswire
Q1 sales rise at Cambrex
Q1 2011 sales at Cambrex rose 9.8% to $61.7m compared to 2010. The company said the increase was due to higher sales of an API to a customer who resolved their supply chain disruption, higher volumes of generic APIs and increased volumes for a recently approved product.
Cambrex
Wednesday, 4 May 2011
Q1 contract revenues grow for AMRI
AMRI saw revenue growth in Q1 2011 driven by its contract manufacturing business. AMRI's development and small scale manufacturing revenue grew 24% to $10.5m and large scale manufacturing revenue grew 22% to $21.8m. The company has recently resumed GMP production at its Burlington, MA, facility and is working with the FDA to close out the Warning Letter as soon as possible.
AMRI
Tuesday, 3 May 2011
Carbogen-Amcis HPAPI facility meets standard
Carbogen-Amcis' new high potency API facility in Ahmedabad, India, has completed a containment performance evaluation. The facility, which is located on the Dishman Pharmaceuticals and Chemicals site, meets category IV standards.
Carbogen-Amcis
Thursday, 28 April 2011
Record sales for SAFC
Sales for Sigma-Aldrich's SAFC division grew by 16% to $180m in Q1 2011 compared to 2010. Kirk Richter, Sigma-Aldrich's Interim Chief Financial Officer, Vice President and Treasurer, said this growth at SAFC was partially due to continued strong demand by biopharma customers as sales of biological drugs continue to expand and also to strong demand for materials and precursors for semi-conductor and LED applications. Rakesh Sachdev, Chief Executive Officer, President and Director, said SAFC has a record level of booked orders for future delivery.
Seeking Alpha
Thursday, 21 April 2011
Strong Q1 for Albemarle
Net sales for Albemarle's fine chemicals business rose 30% to $177.3m in Q1 2011 and income rose 151% to $29.5m. The company said the improvement was due primarily to higher volumes and favourable pricing.
Business Week
Tuesday, 19 April 2011
Monday, 18 April 2011
Bakhu to acquire Phoenix site
Bakhu Pharma has acquired the IP assets of Phoenix Chemicals and is negotiating to purchase the Annan, Scotland, site from the administrators, RSM Tenon. The acquisition is expected to be completed in the next few weeks. Bakhu Pharma was incorporated on 31 March.
BBC
Wednesday, 13 April 2011
Dr Reddy's opens Chirotech expansion
Dr Reddy's has inaugurated the new headquarters for its Cambridge, UK, subsidiary Chirotech and plans to invest further in the site. Chirotech provides development services in the areas of chiral technologies, particularly chemocatalysis and biocatalysis.
Financial Times
Monday, 11 April 2011
Thursday, 7 April 2011
Wednesday, 6 April 2011
Monday, 4 April 2011
BASF increases prices
BASF is increasing the prices of its pharmaceutical excipients and APIs by at least 10% depending on the product group. The company said it is raising prices as a result of a rise in costs for raw materials, energy and labour.
BASF
Tuesday, 29 March 2011
Lonza invests in biomanufacturing
Lonza is to expand its biopharmaceutical manufacturing facility in Slough, UK. The company will invest £16m in a 6000m
The Engineer
Monday, 28 March 2011
Tuesday, 22 March 2011
Angel leases facility
Angel Biotechnology has leased a biomanufacturing facility in Cramlington, UK. The facility, which used to belong to Angel before it withdrew from the site in 2007, will expand Angel's manufacturing capacity five-fold. The company has leased the facility for 15 years and expects to be operational before the end of this year.
Sharecast
Monday, 21 March 2011
FDA and EMA start QbD pilot
The US FDA and the European Medicines Agency (EMA) will launch a three-year pilot program on 1 April to evaluate relevant quality data for new medicines. The Quality by Design (QbD) of pharmaceuticals involves an enhanced systematic and science-based approach to development and manufacturing, to better ensure product quality.
Pharma Times
Thursday, 17 March 2011
Siegfried sales grow in 2010
Siegfried reported sales growing 11% to CHF314.4m in 2010. The company said its API sales grew by 14.1% to CHF252.2m while sales of formulated drug products remained constant.
Chem Manager
Socma and EFCG call for FDA inspections
Socma’s Bulk Pharmaceutical Task Force (BPTF) and European Chemical Industry Council’s Fine Chemicals Group (EFCG) are calling on the FDA to mandate inspections of non-US API manufacturing sites. The two organisations said the FDA should collect a fee for the cost of inspection and the maintenance of a database of inspected sites.
Socma
Thursday, 10 March 2011
Wednesday, 9 March 2011
Tuesday, 8 March 2011
CIA and UKTI seek exhibitors for Chemspec Europe
The UK Chemical Industries Association and UK Trade & Investment are seeking companies for the UK pavillion at Chemspec Europe in June. Grants are available to potential exhibitors.
Contact Neil Harvey for more details
Monday, 7 March 2011
Helsinn to build cytotoxic plant
Helsinn Advanced Synthesis is to build a cytotoxic plant in Biasca, Switzerland. The CHF20m plant will have two production areas. One will have three reactor units capable of producing 10kg batches an the other will have larger reactor units to produce 20kg batches. Helsinn expects to begin commissioning projects for the plat in Q1 2012.
Cleanroom Technology
Wednesday, 2 March 2011
Monday, 28 February 2011
Fujifilm acquires Merck Biomanufacturing Network
Fujifilm has acquired Merck's Biomanufacturing network for $490m. The network consists of the former Avecia facility in Billingham, UK, and Diosynth RTP in Research Triangle Park, NC. Merck has committed to certain continued development and manufacturing activities with Fujifilm.
Bloomberg
Samsung to establish biomanufacturing jv with Quintiles
Samsung and Qunitiles have established a joint venture to provide biopharmaceutical contract manufacturing services in South Korea. Samsung will own 90% of the joint venture company and Quintiles 10%. The jv company will construct its biopharmaceutical manufacturing plant in the Incheon Free Economic Zone in South Korea and be equipped with cutting-edge technologies and 30,000L of mammalian cell culture bioreactor capacity. Groundbreaking is expected in the first half of 2011 and full-scale operation is expected to commence in April 2013.
Bloomberg Business Week
Wednesday, 23 February 2011
Carbogen Amcis to restructure
Carbogen Amcis plans to restructure its three sites in Sqitzerland. Following the restructuring, the Aarau site will focus more strongly on development; the Hunzenschwil site on the pilot production of early phase projects and the Bubendorf site on large-volume production and the manufacturing of highly active agents. The company said that 60 of its 350 staff will be made redundant.
Carbogen Amcis
Monday, 21 February 2011
Alphora to invest $4m
Alphora is investing $4m during 2011 expanding its facilities and capabilities for API technology development. The company said the expansion is to meet growing demand from customers. The company, which recently increased its R&D capacity by 50% by securing new research facilities, is adding isolation technology for its high potency API development services and will add a fourth cGMP kilo lab.
Contract Pharma
Thursday, 17 February 2011
Pfenex links with Boehringer Ingelheim
Pfenex will use its Pfenex Expression Technology to engineer production strains and processes for Boehringer Ingelheim's proprietary molecules, and molecules from Boehringer Ingelheim's contract manufacturing customers. The companies said the partnership will enable preclinical and clinical development to progress much more quickly and efficiently.
San Diego Union-Tribune
Wednesday, 16 February 2011
Profits fall at Dishman
Dishman Pharmaceuticals reported a its net profits fell 94% during its Q3 ended 31 December 2010, while turnover increased 4% to $51m. The company said performance was affected by a lower-than-expected performance at its Carbogen Amcis subsidiary.
Business Standard
FDA to outsource foreign plant inspections
The US FDA is looking to increase the number of overseas plant inspections through the use of third-party inspectors, according to John Taylor, the agency’s acting principal deputy commissioner. The agency is looking to reduce the average of nine yeas between plant inspections overseas.
Bloomberg
Monday, 14 February 2011
Record quarter for SAFC
Sigma-Aldrich's SAFC business unit reported recede sales of $171m in Q4 2010. Sales for the unit in the full year 2010 were $647m up 9% on 2009. Rakesh Sachdev, Sigma-Aldrich cep, president and director said the company is "pleased with the higher level of SAFC's booked orders for future delivery as that is an indicator of future growth for that business". He added that "we expect our SAFC Pharmaceutical business to improve further in 2011" as a result of new added capacity in Wisconsin and California. Additionally, Sachdev said that despite the challenges facing the SAFC Custom Pharma business in Europe the SAFC Custom Pharma business in the US and the international markets is doing quite well.
Seeking Alpha
Wednesday, 9 February 2011
Boehringer to manufacture Elan antibodies
Boehringer Ingelheim will provide technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan.
RTE
Tuesday, 8 February 2011
Ampac adds new facility
Ampac Fine Chemicals has added a second semi-works facility in Rancho Cordova, CA. The company said the facility was part of several capital improvements in progress during 2011 and became fully operational in January. This facility offers a state of the art, remotely operable facility that is designed to safely run hydrogenations, hazardous chemistry and potent compound processes.
Ampac
Monday, 7 February 2011
Large scale manufacturing underpins AMRI revenues
Contract revenues rose 4% at AMRI to $163.2m in 2010. Of this revenues for development/small scale manufacturing fell 4% to $36.5m and revenues for large scale manufacturing grew 13% to $71.0m.
Albany Business Review
Pharma products boost Codexis revenues
Codexis' revenues grew 29% to $107.1m in 2010. The growth was driven by a 77% increase in sales of pharmaceutical products, from $18.6m to $32.8m, and increases in collaborative R&D and government grants. The company reported a net loss of $8.5m a reduction on the loss of $20.3m in 2009. Codexis forecasts revenues of over $120m in 2011.
Codexis
ICIG to buy Genzyme API unit
International Chemical Investors Group is to acquire Genzyme's API manufacturing unit. ICIG will maintain operations at Genzyme's Liestal, Switzerland, facility and rename the unit Corden Pharma Switzerland LLC. As part of the agreement, ICIG will enter into a five-year supply contract to provide Genzyme with materials needed for the production of eliglustat tartrate, an investigational treatment for Gaucher disease Type 1 that is currently in phase 3 clinical trials. Additionally, ICIG will supply materials needed for the manufacture of other treatments in earlier stages of development. Financial terms for the agreement, expected to close during Q1, were not disclosed.
Boston Globe
Wednesday, 2 February 2011
Fine chems grow for Johnson Matthey in Q3
Q3 sales at Johnson Matthey's Fine Chemicals Division improved 10% over last year. The company said sales of APIs remained good, particularly in North America, and the performance of its Pharmaceutical Services business continued to improve.
Johnson Matthey
Monday, 31 January 2011
Recipharm sells Oxford facility
Recipharm has sold its decommissioned manufacturing facility in Oxford, UK, to Oxford BioMedica for £1.9m. Recipharm acquired the facility when it bought Cobra Biologics in 2010. Oxford BioMedica will recommission the plant over the next 12 months to provide production capacity for its proprietary LentiVector gene delivery technology.
Recipharm
New contract as Angel raises cash
Angel Biotechnology will provide pre-GMP services for Pathfinder Cell Therapy's novel cell therapy. Additionally, the company has raised £1.9m in a placing of 553,435,720 ordinary shares.
Angel Biotechnology
Angel Biotechnology
Wednesday, 26 January 2011
Lonza robust in 2010
Lonza reported sales in its custom manufacturing business unit increase almost 2% to CHF1.4bn in 2010. The company said this growth was driven primarily by improved capacity utilisation in large-scale biological manufacturing as a result of new product introductions, especially in the second half of the year. The company has almost 300 products in its chemical pipeline and about 260 in its biological pipeline and reported capacity utilisation rates of around 75% for both businesses. Lonza also said that the build-out of its large scale mammalian biopharmaceutical facility in Singapore is on track, with start-up targeted in Q3 2011. Additionally, TL Biopharmaceuticals, its joint venture with Teva, has commenced a clinical phase-I trials with its first biosimilar product.
Looking forward, Lonza expects to continue to benefit from increased outsourcing of manufacturing and development by pharmaceutical and biotechnology companies, which combined with stronger product pipelines, improved capacity utilisation and a more appropriate cost base, provides the company with a good platform for a solid performance in 2011.
Reuters
Strong 2010 for Albemarle fine chemicals
Albemarle's fine chemicals business unit reported record income in Q4 2010, up 39% on 2009 to $26.3m. The company said the improvement was due primarily to favourable pricing and mix as well as favourable sales and production volumes, which were partly offset by higher variable input costs. The unit saw sales of $569m in 2010 up 13% on 2009. Mark Rohr, Albemarle's Chairman, President and CEO, said the company was looking at a number of potential bolt-ons for the business unit.
Seeking Alpha
Tuesday, 25 January 2011
FDA publishes drug manufacturing guidance
The US FDA has published an industry guidance on the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including APIs or drug substances. The FDA says the guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation guidances for industry.
FDA
Monday, 24 January 2011
ICIG launches WeylChem International
WeylChem International has been launched by International Chemical Investors Group to market the groups custom and toll manufacturing capabilities. In addition, WeylChem will focus on supply chain optimisation between ICIG' fine chemicals businesses in Germany, France, Italy and the US.
WeylChem
Wednesday, 19 January 2011
Monday, 17 January 2011
Phoenix enters administration
ShangPharma starts cGMP facility
ShangPharma has begun operations at its new facility in Fengxian, China. The cGMP multi-purpose pharmaceutical development and manufacturing facility includes a pilot plant with reactor capacities ranging from 200L to 3000L as well as reactors for high temperature, cryogenics, highly toxic and pressurised reactions, including hydrogenation.
Seeking Alpha
Thursday, 13 January 2011
Aurobindo sells subsidiary to Sinochem
Sinopharm is acquiring a 51% stake in Aurobindo Pharma's Chinese subsidiary, Aurobindo (Datong) Bio Pharma Co. Ltd (ADBPL). Sinopharm will later acquire a further 29.5% stake, reducing Aurobindo's holding to 19.5%. Aurobindo will receive $50m for the stake, $23m of which is a repayment of a loan to the subsidiary. Aurobindo's senior manager for investor relations, Tathagato Roychoudhary, said "in the second round of stake sale, Sinopharm will infuse cash into ADBPL to relocate its factory to expand capacity as regulated by the Chinese government".
India Infoline
Wednesday, 12 January 2011
DSM signs enzyme supply agreement with Codexis
DSM Pharmaceutical Products will use Codexis enzymes for commercialisation of sustainable enzyme-based pharmaceutical manufacturing routes developed by its InnoSyn route scouting services.
Codexis
Tuesday, 11 January 2011
Raptor engages Cambrex and Patheon
Raptor Pharmaceutical has engaged Cambrex to manufacture of the API and Patheon to produce the commercial product for its DR Cysteamine its nephropathic cystinosis treatment.
Raptor Pharmaceutical
Euticals acquires Archimica
Italian API manufacturer Euticals SpA will acquire Archimica from TowerBrook Capital Partners. The sale price was not disclosed. Towerbrook acquired the Archimica business from Clariant in June 2006 for approximately €70m. Archimica has approximately 550 employees at six production sites in Italy, France, Germany, US and UK.
Wall Street Journal
Monday, 10 January 2011
Lonza's Borgas wary of strong SFr
Lonza's CEO Stefan Borgas has warned that the strong Swiss franc will be a major challenge for the Swiss economy in the next five years. He added that products made in Switzerland will become less competitive on a global scale.
Reuters
AMRI consolidates drug discovery operations
AMRI has merged its discovery R&D and discovery chemistry departments to form a Global Drug Discovery organisation. The company will combine its discovery chemistry and biology functions into a single unit at its locations worldwide.
RTT
Sunday, 9 January 2011
Dishman facility due online in April
Dishman's facility in Shanghai, China, is expected to begin commercial operations in April. Dishman's CFO, VVS Murthy, says the $10m facility will eventually contribute about $20-25m/year in the future from contract manufacturing of APIs for European clients.
DNA India
Thursday, 6 January 2011
Sinochem buys share of DSM penicillin business
Sinochem has acquired a 50% stake in DSM's penicillin operation for €210 million euros. DSM, which has been searching for a partner for the business for six years aims to unlock sales in one of the world’s fastest-growing markets.
Bloomberg
Subscribe to:
Posts (Atom)
