The Grangemouth-based fine chemicals business KemFine, acquired by Aurelius in November, has been renamed CalaChem

Scottish Enterprise

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

Codexis will supply biocatalysis screening products and services to Dainippon Sumitomo Pharma for use in producing therapeutics in its pipeline

San Francisco Business Times

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

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

Aesica's R5 subsidiary is to add a new analytical laboratory at its Nottingham facility

Aesica

Boehringer Ingelheim has acquired Amgen's Fremont, CA, facility to strengthen its contract manufacturing business

San Francisco Business Journal

Cambrex Zenara's Hyderabad facility has received European cGMP certification from the Danish Medicines Agency

Cambrex

Rentschler Biotechnologie will be the sole manufacturer of Faron Pharmaceuticals recombinant human interferon beta-1a

In-pharma Technologist

Phoenix enters administration

Phoenix Chemicals has told its workforce in Annan, Scotland, and Bromborough, England, that it has entered administration. The company is seeking ways to keep its two facilities open.

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

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

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

Peakdale Molecular has received the French CIR Research Tax accreditation

Peakdale

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

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

Helsinn has sold its Irish plant to IS Pharma for €4.4m

Reuters

Cambrex has appointed Shawn Cavanagh as Executive Vice President and COO, leading Cmabrex's innovator pharmaceutical contract manufacturing operations

Cambrex

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

The EMA is concerned about the quality of non-EU manufactured APIs

In-Pharma Technologist

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

Alexander Wessels is the new President and Chief Executive Officer of DSM Pharmaceutical Products

DSM

Recipharm has set up its pharmaceutical development services business as an individual company, Recipharm Pharmaceutical Development

Recipharm

The FDA approved 21 new drugs in 2010

Wall Street Journal

Dishman Pharmaceuticals has signed a $50m deal to manufacture cardiac drug ingredients for a European pharma company

Economic Times

Angel Biotechnology will produce further batches of ReNeuron's ReN001 stem cells for the next cohort of stroke patients in the PISCES clinical trial

InvestEgate

Novasep's Finorga subsidiary will produce the denufosol tetrasodium an API for Inspire Pharmaceuticals

Yahoo!

Angel Biotechnology has signed a £1.53m antibody process development and GMP manufacture contract with Materia Medica

InvestEgate

Socma has reelected Larry Brotherton as chairman of its Board of Governors

Socma

Onyx Scientific will provide solid dosage form characterisation services for Nuformix

Outsourcing Pharma

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

Stason Pharmaceuticals has licenced Lonza's GS Gene Expression System to develop and manufacture antibodies for tissue necrosis therapy

Lonza

DSM Pharmaceutical Products has licenced c-LEcta's alcohol dehydrogenates for screening programs and process development

PR Newswire

Aesica expands into Europe

Aesica is to acquire three pharmaceutical manufacturing facilities from UCB. Aesica will acquire facilities in Monheim and Zwickau in Germany and Pianezza in Italy. In addition Aesica has signed a long-term supply agreement to supply UCB's products. 600 employees will be transferred from UCB to Aesica. Aesica believes acquisition of the UCB sites "will support and enable its future growth and evolution". Financial details of the deal, which is expected to close in Q1 2011, were not revealed.
Manufacturing Chemist

India plans to increase the number of manufacturing plant inspectors for local an overseas facilities

Business Standard

Aptuit is to shed 340 jobs at two facilities in Scotland

Scotland on Sunday

Currency changes will hit Lonza profits by CHF30m in 2010

Wall Street Journal

Jubilant Life Sciences has completed the demerger of its performance polymers and aggro businesses into Jubilant Industries

Business Standard

Pfenex will supply a cGMP-grade carrier protein to The Henry M. Jackson Foundation for the Advancement of Military Medicine for vaccine development

Almac has added a dedicated late-stage customisation suite for orphan drugs and niche products to its facilities in Craigavon, UK

SP2

Dottikon confirms first half loss

Dottikon

Eden to expand facility

Eden Biodesign is to invest $100m in expanding its Liverpool, UK, manufacturing facility. The company plans to recruit 35 additional staff to fulfil Watson’s five-year contract to develop a Follicle Stimulating Hormone.
Liverpool Daily Post

Good H1 for Johnson Matthey

Sales for Johnson Matthey's fine chemicals division rose 8% to £122m in H1 and for its APIs manufacturing businesses, Macfarlan Smith and Pharmaceutical Materials and Services, sales rose 5% to £88m. The company said that growth at Macfarlan Smith was led by sales of bulk opiates and other controlled APIs and Pharmaceutical Materials and Services' strong performance was mainly due to continued good growth in sales of specialist opiates, amphetamines and platinum anticancer APIs.
Earlier in November, Johnson Matthey acquired a dedicated APIs manufacturing facility in Conshohocken, PA, together with some ongoing businesses. The company said the facility will provide additional capacity and greater flexibility to continue to grow its North American controlled substances business.
Johnson Matthey

Maxygen is to distribute its stake in Codexis to its shareholders

Forbes

Aurelius complete KemFine acquisition

Aurelius has completed its acquisition of KemFine. Aurelius plans to rename the Grangemouth, UK, based operation and expand its product line through acquisitions.
Herald Scotland

WR Grace has completed its acquisition of Synthetech

WR Grace

Lonza partners with California Peptide Research

Lonza has partnered with California Peptide Research to provide small scale synthesis of peptides to the North American market, complementing its existing capabilities across Europe and in Asia. The alliance will provide customers with services from research through commercial supply and enable a seamless transition of projects between CPRI's small-scale facility and Lonza's cGMP facilities.
GEN

Roche to sell Colorado facility

As part of a company-wide programee of job cuts and plant closures, Roche plans to sell its Roche Colorado plant in Boulder. Roche acquired the site 16 years ago as part of its acquisition of Syntex. Roche Colorado is focussed on the production of peptides and employs 280 workers. John Tayer, a Roche Colorado spokesman, said "our expectation is that we will continue to build on our strong record of achievement in the peptide arena both in technical development and manufacturing, and whoever buys us would have a long-term relationship with Roche".
Boulder County Business Report

Angel shares rise

Shares in Angel Biotechnology rose 80% today following the announcement that ReNeuron had commenced its Phase I clinical trial for disabled stroke patients using neural stem cells. Angel manufactures the stem cells for ReNeuron.

InvestEgate

Lonza and Dalton collaborate

Lonza has partnered with Dalton Pharma Services to provide customers, primarily in North America, with early phase chemistry and kg-lab manufacturing services for small molecules.
Lonza

Alpha Biologics has opened its new process development laboratories in Cambridge, UK

Alpha Biologics

Lonza will receive $18m in US defence funding to develop and commercialise its PermaDerm skin substitute

Business Week

Jubilant Life Sciences' profit rose by 41% to $18.5m in its Q2 ended 30 September

Business Standard

Gallus Biopharmaceuticals plans to buy Johnson & Johnson's St. Louis biologics manufacturing facility

St Louis Business Journal

Genmab expects delay in the sale of its Minnesota manufacturing facility

Reuters
Original story: FINE

Mixed results for AMRI

AMRI reported mixed results from its contract manufacturing businesses in Q3 2010. The small scale manufacturing contract revenue decreased 6% to $9.1m, while large scale manufacturing contract revenue increased 20% to $21.9m. Thomas D'Ambra, AMRI's chairman, president and CEO said “results this quarter reflect the continued shift in customer demand for services in Asia and Europe, as evidenced by the on-going growth of our international locations". He also said it would take longer than expected to realise the synergies from AMRI's two recent acquisitions in Wales, UK and Burlington, MA. have shown signs that it will take a few months longer to demonstrate the synergies to our business than we first had anticipated. He added that AMRI was using internal and external resources to address concerns raised in an FDA Warning Letter for its Burlington sterile fill and finish business and hopes to have resolved the matter in H1 2011.
AMRI

Eden Biodesign will provide contract vaccine and gene therapy manufacturing services using Crucell's proprietary PER.C6 cell-line technology

InvestEgate

Angel to add capacity

Angel Biotechnology is planning to add additional GMP capacity in order to meet the demand of new orders and support the company's growth plans. Angel is in advanced discussions to take over a mothballed GMP-standard manufacturing facility, which when fully commissioned would have the potential to increase its GMP manufacturing capacity further by approximately five-fold. The company is also exploring a number of other options, but its preferred choice would be the mothballed facility, which can be brought on line in phases and in a shorter time frame than a new build.
InvestEgate

Aesica is planning to grow its animal health API manufacturing business, particularly in the UK and US markets

NE Business

Dottikon expects loss

Dottikon expects to report considerably lower net sales and a net loss for its H1 2010/11, ended 30 September. The company said this was caused by several discontinued and delayed projects in the late development phase and ongoing currency pressure.
Dottikon

Aesica is looking to expand into Japan

The Northern Echo

Avantor acquires RFCL

Avantor Performance Materials (formerly Mallinckrodt Baker) is to acquire RFCL (formerly Ranbaxy Fine Chemical Ltd) from ICICI Venture. Reports suggest that ICICI has sold around 90% of its holding in a deal worth $101-113m. ICICI Venture had bought RFCL for only $22m. In 2008, ICICI Venture was planning to acquire Mallinckrodt Baker but did not agree a price. ICICI has been seeking a buyer since the summer.
Economic Times
SiFy

Cambrex sales fall

Sales at Cambrex fell 15% to $49.4m in Q3. The company said the fall was primarily due to the timing of orders for certain products, the effects of a supply chain disruption at a customer's facility, a negotiated contract extension for certain drug delivery products resulting in lower volumes and pricing, and lower custom development and controlled substances shipments. However, the company said it had higher sales volume of generic APIs.
Cambrex

The US Patent and Trademark’s Board of Patent Appeals and Interferences has reconfirmed Hovione's patent claims to a method of making flumethasone

Hovione

Dishman Pharmaceuticals & Chemicals reported a 17.9% increase in profit in Q2, but sales fell 2% to $48m

Business Standard

Cambrex has acquired a 51% stake in Hyderabad, India-based Zenara Pharma for $20m and will acquire the remainder in 2016

Street Insider

Jacobs to provide engineering for Porton facility

Jacobs Engineering will provide detailed engineering services for a new multi-purpose GMP manufacturing facility at Chongqing Changshou Chemical Industrial Park, Chongqing, China, for Porton Fine Chemicals.
Jacobs Engineering

Pfenex has launched a Reagent Proteins division to supply lab-grade proteins

Xconomy

GAO unhappy with FDA inspections

The US General Accountability Office has reported that the FDA failed to implement earlier recommendations that would close the gap between the agency’s approach to inspecting domestic and foreign drug manufacturing facilities. Despite a budget increase from $12m in 2008 to $41m in 2009, the agency only inspected 11% of foreign facilities and 42% of US facilities.
Pharmalot

DSM pharma results negative

DSM reported that despite seeing a 4% rise in sales to €168m in Q3, its operating profit was -€6m, below that from the same period in 2009. The company said this was the result of no change in the challenging business dynamics that the entire pharmaceutical industry is facing.
DSM

Codexis acquires rights to IP

Codexis has acquired the MolecularBreeding technology portfolio from its Maxygen for $20m in cash. Codexis will no longer have to make royalty payments to Maxygen, which spun out Codexis in 2002. Codexis will now be able to apply the technology in new markets, subject to previously agreements signed by Maxygen.
Silicon Valley/San Jose Business Journal

Aveo Pharmaceutical has selected Laureate Pharma to produce its monoclonal antibody targeted against ErbB3

Laureate Pharma

Recipharm will manufacture tablets for DuoCort Pharma's orphan drug for the treatment of Addison’s disease

DuoCort Pharma

Swiss Franc and regulators hit Lonza

Lonza said currency exchange to the Swiss Franc was having a impact despite solid sales in Q3. In its Custom Manufacturing business, Lonza said its capacity utilisation and project pipelines continue to increase. In its chemicals manufacturing Lonza has almost 300 projects in the pipeline and is seeing utilisation of almost 75%. In biological manufacturing Lonza has about 240 projects and capacity utilisation just over 75%. The company said the overall positive outsourcing trend it is seeing is counterbalanced by ongoing volatility due to more stringent drug approvals by regulatory authorities, especially in chemical custom manufacturing.
Reuters

Fine chems sales grow in Albemarle Q3

Albemarle's fine chemicals business showed sales grow 7% to $138.4m in Q3 2010. The company said this was due primarily to higher volumes and improved pricing.
Albemarle

SAFC sales grow in Q3

Sales at Sigma-Aldrich's ice chemicals business unit, SAFC, grew 12% to $167m in Q3 2010. The company said this was partly due to improved growth in the sale of bulk chemical products for development and manufacturing. Rakesh Sachdev, Sigma-Aldrich's SVP, CFO and Chief Administrative Officer, expects SAFC sales in Q4 to continue to be strong, but said he expected the comparison to last year will be less favourable than earlier quarters as a result of strong sales of adjuvants for the H1N1 vaccine, which occurred in the fourth quarter of 2009. Jai Nagarkatti, Sigma-Aldrich's Chairman, President, and CEO, said that in Q3 SAFC's pharma sales grew in the US but fell in Europe.
Seeking Alpha

Recipharm is to phase out manufacturing sterile products at its Ashton-under-Lyne, UK, facility

Recipharm

The US Bankruptcy Court for the District of Delaware has approved the proposed acquisition of Synthetech by WR Grace

PR Newswire

Almac has successfully completed and MHRA inspection of its Clinical Services facility in Craigavon, UK

Almac

Reaxa spins out antibody tech

Reaxa has spun out its antibody drug purification technology business. The new company, ADC Biotechnology, will use IP licensed from Reaxa and aims to deliver significant reduction in manufacturing costs for the new generation of cancer drugs based on antibodies.
Manufacturing Chemist

Chinese FDA has released a draft regulation to expand supply chain auditing and filing requirements for API manufacturers

IPQ

Almac invests in biocatalysis

Almac is investing $4m in broadening its biocatalysis R&D expertise. The company said the investment "will be used primarily to focus around discovery of new biocatalytic platforms that can be rapidly implemented and scaled delivering cost effective processes to chiral intermediates".
Almac

SAFC complete Jerusalem expansion

SAFC has completed the expansion of its fermentation capabilities in Jerusalem, Israel. The 5000m² facility, which is expected to begin production during October 2010, will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. 3000m² of the new facility has been designed to be Biosafety Level 2 compliant which provides the company the capability for manipulation of human pathogens.
GEN

BASF adds microreactors

BASF has added two microreactors at its Ludwigshafen, Germany, site to manufacture chemical products on a small scale. One reactor can produce samples of up to about 20 kilograms, and the other can manufacture quantities ranging from one to 50 tonne. BASF said the microreactors operate continuously and are used for reactions that require high pressure or release high levels of heat. The continuous mode of operation and the short reactor residence time of the reaction media ensure end products of consistently high quality.
BASF

Pharmatek Laboratories has added roller compaction to its solid oral dosage form manufacturing capabilities is San Diego, CA

Pharmatek

Elan launches manufacturing business

Elan Drug Technologies launched its Manufacturing Services business at CPhI. The new business provides drug product optimisation, scale-up and commercial scale manufacturing of solid oral dosage forms to pharmaceutical companies.
Elan Drug Technologies

Angel Biotechnology has signed a £100,000 regulatory consultancy contract with Materia Medica

InvestEgate

Lonza receives $35m bond towards $200m expansion in Portsmouth, NH

Fosters Daily Democrat

Jubilant Organosys has changes its name to Jubilant Life Sciences

India Mart

Recipharm has acquired Abbott’s manufacturing site in Parets, Spain for an undisclosed sum

In-Pharm

Saltigo and Reuter Chemische Apparatebau will jointly develop processes for the synthesis of APIs and intermediates

Saltigo

MSD Biologics (formerly Avecia Biologics) will supply ThromboGenics' retinal disorder treatment, microplasmin, for 10 years

Thrombogenics

Carbogen-Amcis will work with EirGen Pharma to manufacture highly potent active ingredients and solid oral-dose products for the treatment of cancer

Carbogen-Amcis

UKTI seeks companies for UK pavilion at ChemSpec Middle East

UK Trade & Investment is seeking UK-based companies offering UK origin (or high UK added value) products and services within the fine and speciality chemical industry with the objective of meeting a Middle Eastern client base at ChemSpec Middle East on 29-30 November 2010.
Chemicals NorthWest

OctoPlus will perform formulation development a global pharmaceutical company's product candidate

OctoPlus

Lonza confirms plans to invest in India

Previous announcement

The Hindu Business Line

DSM and Crucell launch newco

DSM and Crucell have launched Percivia LLC, a joint venture focused on the development of "biobetter" proteins and monoclonal antibodies using their PER.C6 technology. The company, which will be based in Cambridge, MA, will also license the PER.C6 human cell line for production of third party monoclonal antibodies and other proteins.
Crucell

OctoPlus will provide clinical manufacturing for a French biopharmaceutical company

OctoPlus

KemFine UK sold to Aurelius

KemFine has sold its UK facility in Grangemouth to Aurelius. Financial details have not been disclosed and the deal is expected to close later this year. In February, Aurelius acquired Isochem from SNPE.
The Scotsman