Thursday, 20 December 2012

UMN Pharma and its subsidiary Unigen will produce a number of biosimilars using Catalent’s GPEx cell lines


Sartorius Stedim Biotech will market and sell Lonza’s media and buffers used in the manufacture of protein-based therapeutics and vaccines


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

Evonik is cutting 45 jobs at its Tippecanoe, IN, laboratories

JC Online

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.

Angel Biotechnology's losses for its H1, ended 30 September, rose to £2.86m as revenues fell to £1m

Business 7

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.

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.

Carbogen Amcis' Riom, France site for sterile manufacture of fill-finished parenteral drugs was successfully certified by the French Health Agency

Carbogen Amcis

Cadila Healthcare will manufacture intermediates, APIs and finished dosages for some Zambon Group drugs

Financial Express

Kemwell will provide contract manufacturing for Mercury Pharma Group from its facility in Uppsala


AMRI is being sued in Hungary for unpaid lease payments following the closure of its Budapest facility earlier this year

Albany Times Union

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.

Switzerland is the first country to gain acceptance to the EU list of countries with a regulatory framework applicable API manufacture


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

Sigma-Aldrich is re-aligning its business segments and SAFC will be reamed the SAFC Commercial Markets Business Unit

St Louis Business Journal

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

Recipharm will develop and manufacture a parenteral veterinary product for Vetcare


Fujifilm Diosynth Biotechnologies will manufacture ThromboGenics' Jetrea following FDA approval

Fujifilm Diosynth Biotechnologies

Boehringer Ingelheim will install a laboratory-scale reactor of BaroFold’s Pressure Enabled Manufacturing Technology at its microbial facility in Vienna, Austria

Pharmaceutical Business Review

Cytovance Biologics will manufacture Selexys Pharmaceuticals' SelG1 monoclonal antibody for a phase II clinical study


Boehringer Ingelheim will develop E coli production strains and manufacture toxicology and clinical stage material for Molecular Partners’ DARPin pipeline

Molecular Partners

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

ProBioGen has launched a set of engineered, royalty-free biopharmaceutical CHO production cell lines


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.

Wednesday, 7 November 2012

Kemwell will manufacture biosimilar drugs for Avesthagen

Hindu Business Line

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.

Cambrex reported Q3 2012 sales rising 2.8% to $59.8m


Angel Biotechnology has signed a new deal to expand CTX cells and produce the GMP drug substance batch for ReNeuron

The Scotsman

Thursday, 25 October 2012

Althea Technologies will manufacture circumsporozoite protein for Pfenex using Pfenex's production process


DSM Pharmaceutical Products will provide process development and cGMP manufacture of Paranta Biosciences' lead recombinant human protein at its Brisbane, Australia, facility

Fierce Pharma Manufacturing

Fujifilm Diosynth Biotechnologies and Piramal Healthcare UK will jointly offer seamless contract development and manufacture of antibody drug conjugates

Manufacturing Chemist

The US FDA has approved 28 NMEs to date in 2012


John Birch has been appointed as a non-executive director at Cobra Biologics

Outsourcing Pharma

Lonza will develop and manufacture OncoMed’s pipeline of anti-cancer stem cell therapeutics at its mammalian manufacturing facility in Slough, UK


Sigma Aldrich reported a 17% rise in revenues at SAFC to $211m in Q3 driven by a double-digit growth in the custom pharma manufacturing business


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

AMRI has extended its supply contract with Shire for a further five years

Pharmaceutical Business Review

Boehringer Ingelheim has resumed manufacturing at its Ben Venue, Ohio, facility


Sales for Albemarle's fine chemistry business in Q3 2012 were $193.0m up 8% over 2011

Seeking Alpha

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

Ark Therapeutics will manufacture Laurantis Pharma's Lymfactin

Ark Therapeutics

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

Recipharm will provide formulations envelopment for Astimex Pharma at its Solna, Sweden, site

Pharmaceutical Business Review

Wednesday, 10 October 2012

Piramal Healthcare is looking to expand its CRAMS business via acquisitions in the US or Europe

Outsourcing Pharma

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.

Lonza will produce induced pluripotent stem cells for the National Institutes of Health Center for Regenerative Medicine in Walkersville, MD


BASF will launch a production line for precious metal-based fine chemical catalysts in Mangalore, India


Dr Reddy's Laboratories has expanded activated mPEG manufacturing and the development and manufacture of APIs at its manufacturing facility in Mirfield, UK


Olympus Biotech will provide contract biomanufacturing from its state-of-the-art facility in Lebanon, NH

Outsourcing Pharma

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 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

Dalton Pharma Services will provide scale up and manufacture of a conjugate vaccine for tuberculosis developed by the University of Guelph

Research Views

Novasep has appointed Roger-Marc Nicoud as non-executive chairman of the board and Patrick Glaser as president and CEO


AMPAC Fine Chemicals has applied to the US Drug Enforcement Administration to be registered as a bulk manufacturer of Tapentadol

Federal Register

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

Lonza will manufacture of Celladon’s phase IIb-stage targeted enzyme replacement therapy candidate Mydicar for clinical trials


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

Lonza will develop and manufacture Intellect Neurosciences antibody drug conjugate Conjumab-A

Intellect Neurosciences

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.

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

Codexis to cut 133 jobs after deal with Shell terminated

In-pharma Technologist

Tuesday, 4 September 2012

GE Healthcare has launched a range of modular biomanufacturing facilities

In-pharma Technologist

Piramal Healthcare is rumoured to be in talks to acquire Ind-Swift Laboratories' CRAMS business and facilities

Business Standard

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

Mike Ironside has been appointed as General Manager, TTC, at Hovione


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

Angel Biotechnology will develop and manufacture arGentis Pharmaceuticals collagen product for systemic sclerosis

Angel Biotechnology

Conrad Winters has been appointed as Director, Drug Product Development at Hovione

PR Newswire

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

Boehringer Ingelheim reported sales from biopharmaceutical manufacturing falling from €233m to €214m in H1 2012 in the first half of 2012

Boehringer Ingelheim

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.

Siegfried Holding will exchange 80,000m2 of land with the City of Zofingen and StWZ Energie AG, and will obtain land bordering its premises for expansion


Ark Therapeutics and EMD Millipore will collaborate to optimise production of viral based bioengineered vaccines and other live viral products for pilot and production scale

Ark Therapeutics

Laureate Biopharma has developed the process and is manufacturing ZZ Biotech's potential therapeutic for ischemic stroke for phase I clinical trials

Laureate Biopharma

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

Aurobindo Pharma plans to earn 25% of its annual revenues from its custom research and manufacturing business in the next 4-5 years

Economic Times

Gallus BioPharmaceuticals will provide process development and clinical and commercial supply for mammalian cell-based biopharmaceutical products to customers of Theorem Clinical Research

Theorem Clinical Research

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

Boehringer Ingelheim will manufacture gevokizumab for Xoma and Servier at its Biberach, Germany facility, following the transfer of Xoma's berkeley facility to CMC


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.

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.

Dalton Pharma Services provided API development and manufacturing for a Dengue fever clinical trial in Singapore


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

Piramal Healthcare will change its name to Piramal Enterprises following its increase in business activities

Economic Times

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.

ScinoPharm will manufacture topiramate the API for Vivus' Qsymia, approved by the FDA earlier this week


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

DSM Pharmaceutical Products will provide process development and cGMP manufacture for one of Recepta Biopharma's lead antibodies in Groningen, The Netherlands

Pharmaceutical Business Review

Israel and Switzerland have requested exclusion from the EU's rules for API importation

In-pharma Technologist

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.

Aesica plans to add 100 jobs at its Queensborough, UK, facility


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

Lonza has extended its XS Technology platformm to two additional microbial systems: pacha pastoris and bacillius subtilis


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

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

Hovione reposted a 24% rise in sales for the year ended March 2012 to $180m, the sixth consecutive year of sales growth


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

CMC Biologics' Bothell, WA, facility has received GMP certification from the UK Medicines and Healthcare products Regulatory Agency

PR Newswire

Codexis has been awarded the annual Presidential Green Chemistry Challenge Award for its simvastatin manufacturing process


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

Evonik IPO suspended


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

Dalton Pharma Services will manufacture chemicals for use in Clarity Pharmaceuticals’ PET-based companion diagnostics and radio-immunotherapeutics programmes

Pharmaceutical Business Review

Wacker Biotech has completed a feasibility study to produce XL-protein's PASylated therapeutic proteins


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.

SAFC plans to consolidate its global chiral chromatography screening and small scale purification operations at its Pharmorphix laboratories in Cambridge, UK, by July


Evonik IPO may be cancelled


Thursday, 7 June 2012

The US FDA has sent warning letters to eight companies for failing to register manufacturing facilities

In-pharma Technologist

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

Tuesday, 5 June 2012

Codexis has appointed John J Nicols as President and Chief Executive Officer


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.

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.

Albemarle is increasing prices for all grades of ibuprofen by 15%

Fierce Pharma Manufacturing

Angel Biotechnology has successfully completed an MHRA inspection at its Pentlands facility

Angel Bio

Thursday, 24 May 2012

Ian Shott has been appointed as president of AMRI Europe

Albany Business Journal

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

Wednesday, 16 May 2012

Lonza will provide process development and scale-up efforts for manufacturing viral vectors for Avalanche Biotechnologies gene therapy


ReNeuron has contracted Angel Biotechnology to provide GMP stem cell manufacturing services for completion of its stroke clinical trial

Angel Biotechnology

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.

Tuesday, 15 May 2012

API Corporation has added the pharmaceutical ingredient manufacturing and sales operations of Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma

Codexis reported Q1 2012 product revenues of $15.2m up 17% on 2011 driven by increased sales of atorvastatin-related intermediates


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

Angel Biotechnology has acquired the Devro Medical collagen manufacturing business for £200,000


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.

Wednesday, 9 May 2012

BASF has acquired omega-3 fatty acid maker Equateq

In-pharma Technologist

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.

Wacker's Biosolutions unit reported a 9% increase in Q1 sales to €41.2m


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%.

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.

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.

Cambrex’s Charles City, Iowa, API manufacturing facility has successfully completes and FDA GMP inspection

Pharmaceutical Business Review

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

The US FDA has approved Codexis' manufacturing process for sitagliptin the API in Merck's diabetes drug Januvia

Bloomberg BusinessWeek

Dalton Pharma Services will manufacture an antiviral agent developed by Defence Research and Development Canada

Dalton Pharma

Albemarle reposted Q1 2012 sales of $190m for its fine chemicals business, up 7% on 2011 and income of $39 million, up 31%

Seeking Alpha

Kemwell Biopharma has added a 750m2 cGMP pilot plant at its Bangalore, India facility

Outsourcing Pharma

Tuesday, 24 April 2012

AMRI will develop and manufacture Biota Holdings influenza antiviral CS8958

Albany Times-Union

£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

Tuesday, 3 April 2012

Lonza has appointed Richard Ridinger as its new chief executive officer


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

Dottikon has established a US subsidiary Dottikon ES America Inc to meet US business development requirements


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

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.

AMRI will close its operations in Budapest, Hungary, on 30 March, resulting in the loss of 100 jobs

Outsourcing Pharma

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.

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

Angel Biotechnology is seeking to raise up to £1m through a placing of shares


Stuart Needleman has been named President and Chief Operating Officer of Aptuit following promotion from President, Scientific Operations


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.

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

The WHO has joined the inspections alliance formed by the EMA, FDA and TGA


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.

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

Lonza will produce phase I clinical material for Eclipse Therapeutics' novel cancer therapeutic antibody, ET-101 at its facility in Slough, UK


Scott Martin has been promoted to vice president, Fine Chemistry, at Albemarle


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.

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.
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

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.

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.

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

Hikal's Jigani, Bengaluru, API manufacturing facility has successfully completed its third US FDA audit


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.

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.

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

Cambrex will begin supplying commercial quantities of sufentanil and sufentanil citrate in February


Pharmaceutics International has started construction of its 2,400m2 cGMP aseptic fill/finish manufacturing facility in Hunt Valley, MD


Ampac Fine Chemicals Rancho Cordova, CA, facility has been granted registration to manufacture Schedule II controlled substances

Pharmaceutical Business Review

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

Thursday, 19 January 2012

Dishman is planning to sell its Chinese API manufacturing facility in Shanghai

Wall Street Journal

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.

Tuesday, 17 January 2012

Scil Proteins will manufacture Actavis's recombinant protein, Reteplase

Pharmaceutical Business Review

Almac will manufacture MGB Biopharma's gram positive antibacterial compound, MGB-BP3

Manufacturing Chemist

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.

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

Tuesday, 10 January 2012

Pfenex will develop production strains and fermentation process conditions and supply bulk protein to ProZyme for use in research and diagnostics


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

Angel Biotechnology's revenue for the year ended 31 December 2011 was £3.06m