Wednesday, 28 December 2011

AMRI restructures for 2012

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

Angel Biotechnology has raised £1.15m through a placing of new shares

The Scotsman

Sunday, 18 December 2011

Cambrex's manufacturing site in Charles City, Iowa, has received a GMP certificate from the UK's Medicines and Healthcare products Regulatory Agency


Angel Biotechnology has signed a Framework Agreement to develop, scale up and manufacture a recombinant protein product for TransGenRx

RTT News

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

DSM Pharmaceutical Products will manufacture and supply QRxPharma's MoxDuo morphine and oxycodone capsules for the US market through 2015

PR Newswire

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.

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

Lonza is one of a number of companies receiving a share of £8.5m to address challenges in the development of cell based medicines

PM Live

IMCD has acquired Organotec

In-pharma Technologist

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

A UK court has found for Albemarle in a case against AstraZeneca regarding a clause in a supply agreement

Supply Management

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

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

Lonza will manufacture the API for Elan's ELND005

Pharmaceutical Business Review

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.

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

OctoPlus will manufacture an additional drug product for an existing customer


SAFC has commenced conformity testing for the manufacturing process for Oncolytics Biotech's Reolysin

Oncolytics Biotech

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

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

French fine chemicals companies Groupe Novasep and Minakem have denied rumours in Les Echos that Minakem is to acquire Novasep

Speciality Chemicals

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.

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.

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.

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.

Monday, 31 October 2011

SAFC's Verona, WI, HPAPI facility has received SafeBridge certification

Contract Pharma

CMC Biologics has signed a three-year deal to provide process development support and manufacture for several clinical-stage antibodies for Daiichi Sankyo

Pharmaceutical Business Review

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

Prosonix has appointed a scientific board


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.

Panreac has launched Panreac Pharma, to providing GMP compliant excipients and pharmacopoeia grade raw materials

Manufacturing Chemist

Abbott plans to keep its contract manufacturing operations after it spins off its research-based pharma business

Outsourcing Pharma

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.

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

Lonza is considering building a new research centre in Singapore

Today online

Thursday, 20 October 2011

Lonza will begin trading on the Main Board of the Singapore stock exchange on 21 October

Business Times

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

Lonza has completed its acquisition of Arch Chemicals


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

Lonza has successfully completed its tender offer for Arch Chemicals


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

Aesica has entered a long-term strategic partnership with Mitovie Pharma to provide clinical trial and commercial batch supply and formulation development services


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.

Wednesday, 5 October 2011

Aesica will manufacture codeine for Noramco


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

Cambridge Major's Weert, Netherlands, facility has been approved by Dutch authorities

Outsourcing Pharma

The FDA has informed AMRI that the corrective actions underway at its Burlington, MA, facility, should address its investigator's observations


Lonza will provide clinical and long-term commercial production of Mesoblast’s allogeneic adult stem cell products


Novasep will manufacture eicosapentaenoic acid for Photonz Corporation


CMC Biologics unveiled a $10m addition to its Bothell, WA, manufacturing plant

Everett Daily Herald

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

CMC Biologics will manufacture Inspiration Biopharmaceuticals' intravenous recombinant factor IX product

Pharmaceutical Business Review

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

Lonza will manufacture Pasteuria Bioscience's Pasteuria spores at its KouŢim microbial fermentation facility


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

Albemarle is to increase prices for generic APIs by 8-12%, depending on the specific product, from 15 October


Wednesday, 7 September 2011

Oxford BioTherapeutics has licensed CMC Biologics’ CHEF1 expression system for research, development, and commercial use

Oxford BioTherapeutics

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

Camlin Fine Chemicals has been renamed Camlin Fine Sciences

Bombay Stock Exchange

Oxford BioTherapeutics has licensed Lonza’s GS Gene Expression System for research, development and commercial applications

Oxford BioTherapeutics

CMC Biologics has completed the installation of a 2000L single-use bioreactor at its Copenhagen manufacturing facility

PR Newswire

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

BASF has increased prices of APIs and excipients by 10% due to rising costs for raw materials, energy and labour

In-pharma Technologist

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.

CABB has completed its acquisition of KemFine


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

Aptuit will sell its clinical trials supplies business to Catalent for $410m

Philadelphia Business Journal

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.

Dottikon ES will end short hours working at its plants at the end of September 2011 after seeing more new projects


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

Jubilant Organosys has signed a $100m manufacturing deal with an undisclosed global firm

The Hindu

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

Ampac Fine Chemicals will manufacture the API for Chimerix's smallpox drug, CMX001, at its Rancho Cordova, CA, facility

Pharmaceutical Business Review

Tuesday, 9 August 2011

Neuland Laboratories reported revenues rising 14% to $23.2m for its Q1 2012

Neuland Laboratories

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

SynCo Bio Partners has produced the first product batches from its expanded aseptic filling facility

Manufacturing Chemist

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

Cambrex's Q2 sales rose 17.6% to $67.5m primarily due to higher custom manufacturing sales and generic API volumes


Wacker's Biosolutions business generated sales of €39.0m in Q2 2011 up €0.7m from 2010


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.

Wednesday, 27 July 2011

Novasep's Freeport, Bahamas, and Chasse sur Rhône, Lyon, France, facilities passed FDA inspections in March and May respectively


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.

Sigma-Aldrich's SAFC business unit reported sales of $183m in Q2 2011, up 17% on 2010

Seeking Alpha

Thursday, 21 July 2011

Lonza has started its buyout of Arch


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

Mark Griffiths has been appointed as Chief Executive Officer at Carbogen-Amcis


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

Angel Biotechnology has signed a revised contract to manufacture stem cells for ReNeuron's stroke clinical trial

Business Insider

OctoPlus will provide process development and manufacturing for a Danish pharmaceutical company


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.

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

Lonza has instigated 43-hour working at its Visp, Switzerland, facility to offset currency pressures on profitability


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

Cambridge Major Laboratories Europe will manufacture cGMP material for use in clinical studies for Summit's preclinical antibiotic candidate

Manufacturing Chemist

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

Bakhu Pharma has completed the purchase of Phoenix Chemicals' Annan, Scotland, site

News & Star

DSM has introduced new downstream processing technology for for faster and more cost effective production of monoclonal antibodies

PR Newswire

Lonza has introduced a new cell culture medium and feed platform for its GS Gene Expression System that achieves product yields up to 10g/L


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

Lonza has launched a service to offer early stage development and manufacturing of novel biologics


Lonza has received the $260,000 payment it was owed by Regenicin

North Jersey

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.”

Siegfried plan to power its Pennsville, NJ, facility with solar power

Boehringer Ingelheim is expanding its biopharmaceutical fill and finish capabilities in Biberach, Germany

Boehringer Ingelheim

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

Evonik Industries has increased its production capacity for the pharmaceutical amino acid glycine by 50 percent

Pharmaceutical Business Review

RecipharmCobra Biologics will continue to advance KAHR Medical's KAHR-102 for future pre-clinical and clinical testing


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

Lonza has launched the refinancing of its existing CHF500m revolving credit facility


Thursday, 16 June 2011

Intercell's cGMP biologics facility in Gaithersberg, MD, is available for lease

Pharma BioSource Realty

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

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.

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.

Viropro's Biologics Process Development subsidiary will double the size of its bioprocess and scale-up laboratory in Poway, CA


Aesica's facility in Pianezza, Italy, has received accreditation to manufacture and supply non sterile drugs to the Japanese market

Manufacturing Chemist

Laureate Biopharmaceutical Services will manufacture Patrys' lead antibody PAT-LM1 for preclinical and clinical use

Sacramento Bee

Sunday, 5 June 2011

Indian API manufacturers are looking for deals in Japan following after Japanese government opens up its pharmaceutical market to generic drugs

Business Standard

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.

Fujifilm Diosynth Biotechnologies has added a 1,000L Xcellerex Single-Use Bioreactor at its North Carolina facility

Fujifilm Diosynth Biotechnologies

Sales at Onyx Scientific grew 27% to £3.6m in the last year

Technology Networks

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

Boehringer Ingelheim will produce Betaferon for Bayer after Bayer closes its production facility in Emeryville, CA

RTT News

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

SCM Pharma will manufacture Speciality European Pharma's oncology product Plenaxis for commercial supply

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.

Gallus BioPharmaceuticals will use Xcellerex's FlexFactory GMP manufacturing platform suite at its St Louis, MO, facility


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

Almac has dedicated its new North American headquarters

Philadelphia Inquirer

Lactosan will manufacture some enzymes for Codexis and its customers


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.
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.

Pfenex has submitted a Biologics Master File (BMF) to the FDA for its cGMP grade carrier protein for vaccine production


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.

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.

Cristin Grove has been appointed as director, Global Contract Manufacturing at Pfizer CentreSource

Contract Pharma

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.

Gallus Biopharmaceuticals is closing this month on financing for its acquisition of Johnson & Johnson’s Centocor Biologics campus in St Louis

St Louis Business Journal

SAFC will perform process validation and clinical and commercial manufacturing for Oncolytics Biotech's Reolysin, reovirus

Winnipeg Free Press

Synthetech and Oregon State university have launched a new organocatalyst for use in pharmaceutical production


SynCo Bio Partners will manufacture Syntaxin's drug candidate SXN101959 for non clinical and clinical trials

Pharmaceutical Business Review

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

DSM and Roquette are to build a 10,000 tonne/year plant for the production of bio-based succinic acid in Cassano Spinola, Italy


Sales for Wacker Biosolutions in Q1 grew 10% to €37.7m with strong demand for products used in pharmaceutical and agrochemical applications


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.

Wednesday, 4 May 2011

Aptuit will provide manufacturing scale-up services for Iroko Pharmaceuticals' novel pain medications for Phase III clinical trials

Iroko Pharmaceuticals

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.

SAFC will manufacture the API for Pro-Pharmaceuticals' lead product candidate for anticipated use in clinical trials and sales in Colombia


Tuesday, 3 May 2011

Cambridge Major Laboratories has appointed Rick Proehl as Vice President of Manufacturing


CMC Biologics has appointed Claes Glassell as CEO

CMC Biologics

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.

Thursday, 28 April 2011

Sales fell 14% at DSM's pharma business reflecting a drop in volumes in DSM Pharmaceutical Products


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

TG United will provide commercial-scale manufacturing for Adeona Pharmaceutical's reaZin

Adeona Pharma

Hebei Aoxing API Pharmaceutical Company has adopted advanced process technology from Macfarlan Smith to manufacture naloxone hydrochloride API

In-pharma Technologist

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

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.

Wednesday, 13 April 2011

Lonza reported a good Q1 2010 but warned that the strong Swiss franc and high raw material prices would dent its H1 performance


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, 4 April 2011

Kevin Cook has been appointed as Managing Director of Aesica's API business unit


Following completion of the acquisition, Fujifilm has renamed the Merck Biomanufacturing Network as Fujifilm Diosynth Biotechnologies

Contract Pharma

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.

Tuesday, 29 March 2011

Almac has expanded its biopharmaceutical cold storage facilities in Craigavon, UK

outsourcing Pharma

Lonza invests in biomanufacturing

Lonza is to expand its biopharmaceutical manufacturing facility in Slough, UK. The company will invest £16m in a 6000m2M/sup> building including a fermentation suite, purification suites, process development laboratories and a GMP warehouse. The company expects the facility, which will allow it to respond to a broader range of customer projects, to be completed by the end of 2012.
The Engineer

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.

Monday, 21 March 2011

Lonza will provide cell line and process development for Athera Biotechnologies' monoclonal antibody PC-mAb

Karolinska Development

Contract manufacturer issues delay Regenrx clinical trial

Washington Business Journal

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

Boehringer Ingelheim will provide process development and manufacturing of additional clinical material for MorphoSys's proprietary MOR208 antibody


Lonza will provide process validation and commercial manufacturing Enobia’s bone-targeted enzyme replacement therapy ENB-0040


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

Amgen is to buy Pfizer's Dun Loaghaire, Ireland, manufacturing plant and will manufacture products for Pfizer


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.

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

Evonik has acquired Boehringer Ingelheim Pharma's Resomer polymer technology for use in medical and pharmaceutical formulations

Chemistry Views

Brian Scanlan will succeed Michael Major as president and chief executive of Cambridge Major Laboratories

Milwaukee-Wisconsin Journal Sentinel

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

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.

Angel Biotechnology made its first pre-tax profit of £0.19m on revenues of £2.95m during 2010

Proactive Investors

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

David Anton has been promoted to chief technology officer and senior vice president, process development and manufacturing at Codexis

Silicon Valley / San Jose Business Journal

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

Viropro has acquired Alpha Biologics for $21m

Business Weekly

An affiliate of Sun European Partners has acquired NextPharma Technologies


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

Angel Biotechnology will establish a new manufacturing facility in Newcastle, UK

The Herald

SAFC has completed the first projects at its large scale High Potency facility in Verona, WI


Wednesday, 16 February 2011

Endeavour Speciality Chemicals has added compounds for oncology research and novel thioamides to its building blocks and reactive intermediates range

ImPress PR

Robinson Brothers has invested £300,000 in a calorimetry lab for scale-up process safety


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.

Angel Biotechnology has signed a five year pricing agreement with Materia Medica with a potential value of over £4.5m

Angel Bio

Q4 2010 sales at Cambrex rose 8% to $63.5m as a result of order timing and higher API sales

In-pharma Technologist

Monday, 14 February 2011

Merck's BioManufacturing Network will manufacture large scale GMP clinical supplies of Nuron Biotech's NU100 recombinant human interferon beta


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

Novasep has partnered with instrAction to develop and operate or supply optimised large-scale chromatography processes to purify taxane-based APIs

In-pharma Technologist

DSM Biologics has achieved 11.5g/L tiers using its XD process technology with a CHO cell line producing an Fc-fusion protein


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.

The assets of Phoenix Chemicals in Arran and the Wirral, UK, are for sale by the administrators

Winter Hill

DSM Biologics will provide process development and cGMP manufacturing for NKT Therapeutics lead product iNKT mAb


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.

Dalton Pharma will provide cGMP API manufacturing and fill/finish services for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund


ScinoPharm will provide commercial manufacturing for Clinical Data's vilazodone hydrochloride API


KaloBios Pharmaceuticals will use BioWa and Lonza's Potelligent CHOK1SV cell line for the development and production of its Humaneered antibodies

Genetic Engineering News

Almac has opened analytical labs at its new headquarters in Pennsylvania

Outsourcing Pharma

Monday, 7 February 2011

Former Biogen Idec President and CEO, James Mullen, has been appointed as CEO of Patheon

Research Triangle News

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.

Nitto Denko has acquired Avecia Biotechnology, the DNA- and RNA-based therapeutics manufacturer

Mass High Tech

AMRI's Burlington, MA, facility has received approval from the Italian Medicines Agency for the manufacture of octreotide for a customer in the EU


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

RecipharmCobra Biologics has been granted European patents on its Xer-cise genetic engineering technology


Carbogen Amcis has installed new stability study capabilities at its Hunzenschwil, Switzerland-site to meet ICH guidelines

Contract Pharma

Wednesday, 2 February 2011

Informex returns to New Orleans, 14-17 February 2012


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

Laureate Pharma has changed its name to Laureate Biopharmaceutical Services

Laureate Biopharma

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.

Lonza is to repurchase one million shares during the next year


Phoenix Chemicals has made 36 people redundant at its Wirral, UK, site and 7 redundant at its Annan site

Wirral News
Dumfries and Galloway Standard

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

Pfenex will develop a scalable production process for a key Malaria antigen in a $3.1m subcontract from SAIC


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.

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

Tuesday, 25 January 2011

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.

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.

Monday, 17 January 2011

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

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.

Peakdale Molecular has received the French CIR Research Tax accreditation


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.

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


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


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.

Sunday, 9 January 2011

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


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


The FDA approved 21 new drugs in 2010

Wall Street Journal